JP2016197092A - System and method for detection of gamma radiation from radioactive analyte - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a system and method for measurement of radiation emitted from an in-vivo administered radioactive analyte.SOLUTION: Gamma radiation sensors are used to determine proper or improper administration of a radioactive analyte. In some cases, the system employs a sensor having a scintillation material to convert gamma radiation to visible light, which enables embodiments of the sensor to be ex vivo. A light detector converts the visible light to an electrical signal. The signal is amplified and is processed to measure captured radiation. Temperature of the sensor is recorded along with this radiation measurement for temperature compensation of ex vivo embodiments. The sensor enables collection of sufficient data to support separate application to predictive models, background comparisons, or analysis.SELECTED DRAWING: Figure 1

Description

  The present invention is a measurement and prediction of biological processes, more specifically, measurement of local accumulation of radiolabeled tracers over time and prediction of biological processes, as well as ensuring proper injection or administration of radiolabeled tracers. Related to systems and methods that can be

  This application is part of US patent application Ser. No. 13 / 840,925 filed on Mar. 15, 2013, which claims the benefit of priority of US Provisional Application No. 61 / 653,014 filed on May 30, 2012. It is a continuation application, and all the contents are included here to claim its right.

  It is important for oncologists to know whether the prescribed cancer treatment is working as intended to improve outcomes, reduce side effects, and avoid unnecessary costs. Chemotherapy kills tumor cells. Cytostatic therapy inhibits cell growth and prevents tumor growth while preventing metastasis. Immunotherapy uses the immune function to attack cancer, but the tumor area first becomes inflammatory before evidence is available that the body is effectively attacking the tumor. Measuring tumor size is the primary means of assessing treatment effectiveness for oncologists, but it is well known that tumor size is not the best or early indicator for assessing treatment effectiveness Is the fact of In chemotherapy, tumor shrinkage often takes several weeks because cancer cells are necrotic and can only be confirmed after necrotic cells are metabolized by the body's metabolic function. Cytostatic therapy suppresses the growth of cancer cells, but the underlying cancer state remains unknown to the clinician. In immunotherapy, inflammatory reactions often hinder proper assessment of tumors.

  Currently available assessment methods are not ideal for oncologists and researchers to assess tumor response to treatment. Although palpation of tumors is an easy and inexpensive method, it is limited to tumors close to the body surface, relies on physician memory and records, and is primarily a measure of size. Due to the lack of reproducibility of the palpation process and the circumstances so far, a remarkable change in the size of the tumor was first spread as an evaluation index for treatment (Wolfgang A. Weber et al., Non-Patent Document 1). Diagnostic imaging (CT, MRI, X-ray) provides more accurate measurements for both near body surface and deep tissue tumors, but is still primarily a measure of size, which is an ideal indicator is not. Molecular diagnostic imaging (PET / CT scan) detects positron emission in the amount of living cancer cells that have accumulated in an injected radiolabeled tracer and is usually used as a staging before cancer treatment Is done. Although the visual identification of metastases is the primary means of diagnosing cancer stage, semiquantitative PET / CT measurements known as SUV (standard sugar metabolism or semiquantitative standardized absorption value) are also Used for stage diagnosis. For example, SUVs are used to diagnose whether lung nodules are malignant. SUV is basically the ratio of the area of interest (tumor) and the amount of radiolabeled tracer accumulated throughout the body. Although molecular imaging is the primary method for diagnosing a patient's cancer stage prior to treatment, molecular imaging can detect cancer metabolism or growth status and tumor size, so Researchers are beginning to gain popularity as the best method for assessing tumor response. Comparison of the SUV calculated from the initial PET image obtained approximately 60 minutes after injection or administration of the radiolabeled tracer with the PET / CT SUV at follow-up will help evaluate the effectiveness of the current treatment. Is the best indicator.

  As clinical validation continues to increase, there is an increasing tendency to evaluate tumor response to more cancer types by comparison with PET / CT scans, but this latest evaluation method is also limited. PET / CT scans are expensive and often cannot be used easily. In addition, there are several problems with SUV calculations. According to Dominique Delbeke, “The reproducibility of SUV measurements is, for example, the amount of extravasation, the imaging time after 18F-FDG administration, the type of reconstruction algorithm, the type of attenuation map, the size of the region of interest, the tumor It depends on the reproducibility of clinical protocols such as changes in accumulation due to organs other than those, and analysis methods (for example, maximum value or average value) ”(Dominique Delbeke et al., Non-Patent Document 2). Extravasation (exudation) of radiolabeled tracers is a side effect that clinicians often overlook (Medhat Osman, Non-Patent Document 3). Extravasation is a common side effect in which the radiolabeled tracer exudes to the tissue in the vicinity of the venipuncture site, and is caused by the distal end of the catheter coming out of the vein or penetrating the vein. Furthermore, a part of the tracer may exude from the blood vessel wall into the surrounding tissue. As a result, the dose of radioactive tracer is inaccurate, so the SUV calculation is also inaccurate and can have a significant impact on patient treatment and study conclusions. This exudation may contribute to the fact that there is significant variation despite the efforts of researchers who want to specify SUV thresholds in making clinical decisions. According to one study, “threshold of metabolic response in groups that cannot guarantee quality due to multiple facilities, multiple observations, etc. was -34% to 52%, whereas in groups that had quality assurance by centralized management, it was -26% to 39%. It was a range "(Linda M. Velasquez et al., Non-Patent Document 4). These problems associated with SUV calculations are also present in general facilities, or facilities and research centers that conduct quality assurance checks, so that oncologists and researchers are prominent in achieving adequate treatment evaluation or research outcomes. Requires a change in SUV.

  In current clinical settings, using SUV comparisons from PET / CT still images is the most effective way to assess tumor response to therapy, but video (radiolabeled tracer accumulation over time (PET images acquired) have provided researchers with dynamic information regarding the accumulation of radiolabeled tracers. It has been demonstrated in academia that this dynamic information is better suited to assessing treatment and predicting patient outcomes than using static SUVs (Lisa K. Dunnwald, 5). Unfortunately, however, this dynamic PET requires about three times the time of a static PET / CT scan, so it is necessary to add a PET scanner to implement it. Clinically and economically unreasonable for clinical use. Thus, while there have been significant improvements in cancer treatment options over the past few decades, oncologists and researchers have the timeliness necessary to assess the effectiveness of the treatment being prescribed or the effectiveness of the study. Does not yet have a cheap, quick means.

  In light of these problems with existing tumor measurement and prediction systems, the purpose of the present invention is to identify inappropriate radiolabeled tracer administration (extravasation or exudation) that adversely affects tumor accumulation and PET results. And to provide an easy, inexpensive and effective system and method that can measure and predict the state and changes of biological processes.

“Use of PET for Monitoring Cancer Therapy and Predicting Outcome”, 46 J. Nucl. Med. (No. 6) 983-995 (June 2005). “Procedure Guideline for Tumor Imaging with 18F-FDG PET / CT 1.0”, 47 J. Nucl. Med. (No. 5) 885-895 (May 2006) “FDG Dose Extravasations in PET / CT: Frequency and Impact on SUV Measurements”, Frontiers in Oncology (Vol. 1:41) 1 (2011) “Repeatability of 18F-FDG PET in a Multicenter Phase I Study of Patients with Advanced Gastrointestinal Malignancies”, 50 J. Nucl. Med. (No. 10) 1646-1654 (October 2009) “PET Tumor Metabolism in Locally Advanced Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy: Value of Static versus Kinetic Measures of Fluirodeoxyglucose Uptake”, Clin. Cancer Res. 2011; 17: 2400-2409 (first published online on March 1, 2011 )

  This disclosure identifies improperly administered radiolabel tracers, reduces radiolabel tracer dose, and reduces patient discomfort easily, quickly, and relatively inexpensively to integrate radiolabel tracers with biological systems It is a system that can measure. This system can perform a biological process in a laboratory animal at a lower cost with a higher processing speed than existing systems. Physicians and researchers can perform appropriate treatment and research results more inexpensively and effectively. The embodiments of the system of the present invention described below relate to quality control confirmation and measurement and prediction of tumor changes to identify improperly administered radiolabeled tracers. System embodiments can be used to measure the process in any biological system. For example, the system can also be used for intracerebral scans not related to tumors, evaluation of inflammation, evaluation of renal function, and the like.

  In any example embodiment of the invention, hardware that indicates that administration of a radiolabeled tracer infusion was appropriate and that collects real-time measurements of the absorption of the radiolabeled tracer at in vivo effects, eg, a tumor, and There is a software system. The sensor measures the local absorption of the radiolabeled tracer administered to the patient or subject. In certain embodiments, for example, the sensor comprises (1) directly above the tumor, (2) the right upper arm about 10 cm above the anterior elbow, (3) the left upper arm about 10 cm above the anterior elbow, and (4) Install in other regions of interest. By placing the sensor on the upper arm, i.e. just above the injection site of the radiolabeled tracer, the device can evaluate whether relatively common side effects have occurred in the injection of the radiolabeled tracer. If radiolabeled tracer injection is appropriate, it passes under the sensor of the injected arm within seconds after injection. In the case of extravascular leakage or exudation, it remains in the tissue of the arm outside the blood vessel and is detected by the arm sensor.

  In any example embodiment, sensor measurements are performed quickly and iteratively. The system of the present invention reduces the amount of expensive radioactive tracers required for accurate measurements, compared to other measurement methods, and is a large PET scanning device or a similar device capable of tracking scanning (PET / CT scanning). The device can also be used for staging of diagnosed cancer and for examination of metastases). Measurements using existing approaches clarify tumor dynamics. Compared to healthy tissue, tumors differ in local digestion of radioactive specimens due to biological differences. The present invention senses and quantifies this amount of digestion and graphs the data for oncologists so that it can be easily read within minutes. Transition of tumor parameters is shown by comparing graphs over time (reference values vs. subsequent scans). Changes in biological parameters within the tumor can provide doctors with insights into whether the treatment is working. Furthermore, the present invention predicts changes in biological parameters from a single measurement scan using a prediction algorithm, thereby reducing the time required to know the expected therapeutic effect.

  In any embodiment, the system includes (1) one or more measurement sensors, (2) one measurement control device, (3) computer software that can perform measurements and predict data, and (4 ) Consists of database server management software.

  In one embodiment, the measurement sensor comprises a scintillation material, a photodetector, a processor with associated embedded software, a memory, logic on the printed circuit board, and other circuitry. In one embodiment, for example, the sensor electronics are sealed in a light-shielding housing with a multi-conductor cable that allows data communication. The scintillation material can be managed at an accurate position by the mechanical design of the housing.

  In one embodiment, the measurement control device includes, for example, a display screen, a keypad, and a data communication connector. The control device may be added with a processor, memory, real-time clock, logic on the printed circuit board, and other circuits with associated embedded software. In one embodiment, a plurality of data communication connectors are provided so that a plurality of measurement sensors can be connected. Another example embodiment of the control device also includes a data communication connector that can be connected to a computer.

  In any example embodiment, the specialized computer software used in the system of the present invention is (1) performing a diagnostic test of the measurement control device, and (2) transferring measurement data from the measurement control device to a recording file. Storage, (3) collection of data (e.g. dose administered, patient weight, patient blood glucose, PET scan data, etc.) related to examinations from the user or other information sources, (4) database records from data recording files Functions such as transfer to server management software.

  In any example embodiment, the database server management software can receive a received data record file from a computer and execute one or more algorithms on the received data. A simple algorithm can perform, but is not limited to, smoothing and / or noise reduction, correction of radioactive attenuation, amplitude correction by a control signal, and the like. More complex algorithms can be machine learning algorithms such as classification decision trees, rule learning, induction logic, and Bayesian networks. Measurement data can be stored in a central database while generating reports from the algorithm output for the user. These reports also show estimated parameters of tumors or other biological processes, or future estimated parameters.

  In an example of some system embodiments, a change over time from administration to accumulation of a radioactive specimen that decays in vivo due to positron emission is detected in real time by gamma rays emitted from a subject. Objective. These systems can have at least one computer processor having at least one extracorporeal measurement sensor, non-transient memory and a clock, the computer processor interacting with the measurement sensor, temperature corrector and computer program code. Interlocked. The external measurement sensor can include a sensor housing, a scintillation material, a photodetector, a temperature sensor, a signal amplifier, and a sensor power supply device. Basically, the photodetector, the temperature sensor, the signal amplifier, and the power supply device for the sensor are linked by mutual communication. The scintillation material and the light detector are arranged in a light-shielded state in the sensor housing, and the scintillation material detects a certain level of gamma rays from a radioactive sample in the body for a certain period of time, and generates photons that match the gamma ray level. Adapted to release. The photodetector can be placed in pairs with the scintillation material to sense photons and convert them into signal data that represents the frequency level of the detected gamma rays over time. The signal amplifier is configured to amplify the signal data, and the measurement sensor has at least one sensor output for the amplified signal data.

  The at least one computer processor can include non-transient memory and a clock, and the computer processor interacts with the measurement sensor. The memory has control computer program code executable by at least one computer processor. The computer program code for control includes a plurality of software modules such as a first module for measurement and a second module for data management (“module” simply indicates a part of the function of the software program code).

  The temperature corrector is paired with the temperature sensor in order to adapt the temperature sensor to measure the ambient temperature. This allows the system to communicate the ambient temperature to the temperature corrector, which can calculate a temperature correction factor by comparing the ambient temperature with the reference temperature. Further, the temperature corrector employs a temperature correction coefficient in the signal data so as to be adapted to calculate the temperature-corrected signal data.

  The first module is adapted to receive the signal data in the recording file format, and the second module can receive the recording file signal data from the first module and transmit the corrected signal data to a predetermined recording device. Fits. The computer program code is further adapted to receive stored record file data from the second module and to use the stored data to calculate a corrected signal data change over a predetermined period of time. Is included. The module can also use the stored data as a prediction model, generate a prediction data value as a prediction output over a predetermined period for the recording file, and send such changes to a predetermined recording device.

  Optionally, the external measurement sensor includes a radiation shielding mask for gamma rays. The shielding mask defines an opening as a collimator for gamma rays incident on the scintillation material. The alignment function or device includes the measurement sensor so that the position of the measurement sensor can be aligned with the subject even if it is detached. In some cases, the alignment function includes a light emitter disposed within the sensor and allows the collimator opening to be aligned with a predetermined site of the subject by being applied to the subject. Optionally, the light emitter can be a light emitting diode (LED) disposed within the aperture, and optionally, the external measurement sensor can be scintillated with output light (or ambient light) from the diode. Gamma rays incident on the scintillation material can be hit while preventing it from hitting the material, and a light shielding seal material is provided in the vicinity of the LED.

  Optionally, the in vitro measuring sensor can further include a radiation shielding mask for gamma rays, which defines an opening in the form of a collimator for gamma rays incident on the scintillation material. In addition, the system further includes a stand-type alignment device that allows the external measurement sensor to be attached to and detached from the subject so that the opening of the collimator can be aligned with a predetermined portion of the subject. Or include functionality.

  Optionally, the third module can detect extravasation. In one approach, the third module can calculate a corrected signal data transition to determine extravasation of the radioactive specimen. In another approach, the predictive model includes data representing the frequency of radiation over time for extravasation of the specimen in the subject to determine extravasation. Such a predictive model includes data representing the peak of radiation frequency over time after administration of the specimen in order to confirm proper administration of the specimen. An alarm or detector may be included to signal extravasation. Further optionally, some example embodiments include an armband for releasably securing an external measurement sensor to a subject's arm.

  Optionally, a noise reduction filter is included to filter the amplified signal data based on amplitude or pulse height. This filter can work with a voltage comparator. Alternatively, the filter includes an analog-to-digital converter and control computer program code adapted to compare the amplified signal digital data with a reference level.

  As an example of a further embodiment of the system, a change over time from administration to accumulation of a radioactive specimen that has decayed in the body due to positron emission is intended for real-time detection of gamma rays emitted in the region of interest of the subject outside the body. To do. The embodiment includes a first extracorporeal measurement sensor and a second extracorporeal measurement sensor. The first integrated measuring sensor is a sensor housing having a radiation shield that defines a cavity, and the radiation shield can define an opening into the cavity, and a collimator disposed within the opening is of interest. The scintillation material can be placed in the cavity so that gamma rays collimated from the region into the cavity can be incident, and the photodetector can be placed in the sensor housing so that the light emitted from the scintillation material can be detected. Includes a housing, temperature sensor, signal amplifier, and sensor power supply. The photodetector, the temperature sensor, the signal amplifier, and the sensor power supply device are linked by mutual communication.

  In general, scintillation materials and photodetectors are used for sensors together with scintillation materials adapted to receive a level of gamma radiation from a radioactive specimen in the body during a predetermined period of time and to emit photons corresponding to the level of gamma radiation. Place in the enclosure. As described above, a photodetector that can be placed in pairs with a scintillation material is adapted to be converted into signal data representing the frequency level of gamma rays over time by the multiplied photons. The signal amplifier can amplify the signal data, and the measuring sensor has at least one sensor output or port for the amplified signal data.

  In this embodiment, the second external measurement sensor may be in an unshielded state for measuring background gamma rays. In addition, the collimation alignment system works in communication with the sensor housing so that the collimator can be aligned with the region of interest.

  The temperature corrector is paired with the temperature sensor in order to adapt the temperature sensor to measure the ambient temperature. The system is adapted to communicate the ambient temperature with a temperature corrector, which calculates a temperature correction factor based on a comparison between the ambient temperature and a reference temperature. The temperature corrector can be further adapted to apply temperature correction factors to the signal data to generate temperature correction signal data.

  The at least one computer processor can include a non-transient memory and a clock, and the computer processor interacts with the first and second measurement sensors. The memory has or stores control computer program code executable by at least one computer processor, the control computer program code having a first module for measurement and a second module for data management. It is. The first module is adapted to receive signal data in a recording file format. The second module is adapted to receive the recording file signal data from the first module and transmit the corrected signal data to a predetermined recording device. Also, the computer program code can include third and fourth modules, the third module can receive the stored data of the recording file from the second module, and (1) the stored data can be applied to the prediction model and the recording Prediction data values over a predetermined period relating to a file can be generated as a prediction result, and the prediction result can be transmitted to a predetermined recording device. (2) Corrected signal data over a predetermined period by applying the stored data The fourth module is configured to calculate the signal data from the second external measurement sensor from the signal data from the first external measurement sensor. Can be configured to subtract.

  This embodiment is suitable as a first extracorporeal measurement sensor and can include options corresponding to the options of the previous embodiments.

It is a figure which shows the outline | summary of a system. It is a figure which shows the sensor for a measurement which is an example of embodiment of a system. It is a figure which shows embodiment of the sensor for a measurement of a system. FIG. 6 illustrates possible system options. FIG. 6 illustrates possible system options. FIG. 6 illustrates possible system options. It is a figure which shows embodiment of the control apparatus for a measurement. It is a figure which shows embodiment of the control apparatus for a measurement. It is a figure which shows embodiment of the control apparatus for a measurement. It is a figure which shows an example of embodiment of the computer program code of a system. It is a figure which shows an example of embodiment of a printed circuit board and a light-shielding body. It is a figure which shows an example of embodiment of a light-shielding body. It is a figure which shows an example of embodiment of a light-shielding body. It is a figure which shows an example of embodiment of a system. It is a figure which shows embodiment of the sensor for a measurement. It is a figure which shows embodiment of the sensor for a measurement. It is a figure which shows where a sensor is installed in a test subject's body. It is a flowchart which shows an example of embodiment of a system component. It is a figure which shows an example of embodiment of a system. It is a figure which shows an example of embodiment of the sensor for a measurement. It is a figure which shows an example of embodiment of the sensor for a measurement. It is a detailed exploded view of an example of an embodiment of a sensor for measurement. It is a flowchart which shows an example of embodiment of operation | movement of the sensor for a measurement. It is a figure which shows an example of embodiment of the control apparatus for a measurement. It is a front view figure which shows an example of embodiment of the control apparatus for a measurement. It is a front view figure which shows an example of embodiment of the control apparatus for measurement to which the sensor for measurement was connected. It is a flowchart which shows an example of embodiment of operation | movement of the measurement control apparatus. It is a flowchart which shows an example of operation | movement of the computer software of embodiment. It is a flowchart which shows an example of operation | movement of the database management software of embodiment of a system. It is a figure which shows the output from the sensor of the inject | poured arm when administration or injection | pouring of a radiological sample is appropriate. It is a figure which shows the output from the sensor of the inject | poured arm when administration or injection | pouring of a radiological sample is improper. It is a figure which shows the output from the sensor of the inject | poured arm when administration or injection | pouring of a radiological sample is improper. It is a figure which shows an example of embodiment which combined the sensor for measurement and the control apparatus for measurement with an example of embodiment of an armband. It is a figure which shows an example of embodiment which combined the sensor for measurement and the control apparatus for measurement with an example of embodiment of an armband. It is a figure which shows an example of embodiment of a light-shielding body. It is an exploded view of an example of an embodiment of a light-shielding body, and a light-shielded internal structure. It is a figure which shows an example of embodiment of the light-shielding body combined with the light source for position alignment. It is a figure which shows an example of embodiment of the light-shielding body combined with the light source for position alignment. It is a figure which shows an example of embodiment of the light-shielding body combined with the light source for position alignment. It is a figure which shows an example of embodiment of the control apparatus for a measurement. It is a figure which shows an example of embodiment of the connected two control apparatuses for a measurement. It is a figure which shows an example of embodiment of the sensor for a measurement. It is a figure which shows an example of embodiment of the sensor for a measurement. It is an exploded view of an example of an embodiment of a light shield arranged in an example of an embodiment of a sensor for measurement. It is a figure which shows an example of embodiment of the apparatus for position alignment of a radiation shielding mask. It is a figure which shows an example of embodiment of the apparatus for position alignment of a radiation shielding mask. It is a figure which shows an example of embodiment of a radiation shielding mask. It is a top view of an example of an embodiment of a radiation shielding mask and a collimator. It is a bottom view of an example of an embodiment of a radiation shielding mask and a collimator. It is a figure which shows an example of embodiment of the sensor for a measurement attached to an example of embodiment of a radiation shield. It is a figure which shows an example of embodiment of the apparatus for position alignment of a radiation shield, and an example of embodiment of radiation shielding. It is sectional drawing of an example of embodiment of the sensor for measurement attached to an example of embodiment of a radiation shield. It is sectional drawing of an example of embodiment of the sensor for measurement attached to an example of embodiment of a radiation shield. It is sectional drawing of an example of embodiment of the apparatus for position alignment of the radiation shield attached to the example of embodiment of a radiation shield. It is a figure which shows an example of embodiment of the sensor for a measurement attached to the sensor stand for a measurement, and the attached radiation shield. It is a detail drawing of an example of an embodiment of a sensor for measurement. An example of embodiment of a sensor for measurement attached to an example of embodiment of a radiation shielding mask which has an adjustment foot is shown. It is a figure which shows an example of embodiment of the sensor for a measurement attached to an example of embodiment of the radiation shielding mask which has an adjustment leg. It is a figure which shows an example of embodiment of the sensor for measurement linked. It is a figure which shows an example of embodiment of the sensor for measurement linked. It is a figure which shows three examples of embodiment of the sensor for a measurement. It is a figure which shows an example of embodiment of the sensor for a measurement to which the external press button was attached. It is sectional drawing of an example of embodiment of the sensor for a measurement which has a backscattering material. It is a figure which shows an example of embodiment of the housing | casing for measurement sensors which has a structure which can fix the arrangement position of a backscattering material. It is a flowchart which shows the method of implementing this method.

  The present disclosure is a system for measuring gamma rays emitted from a radioactive analyte administered in vivo. If the measurements are repeated, they show a change in the measured radiation dose over time. These repeated measurements can be used to calculate parameters associated with the data. Repeated measurements can also be used as input data for a prediction algorithm for predicting future parameters.

  The system consists of a hardware and software system for collecting real-time or dynamic measurements where radiolabeled tracers are integrated in biological processes such as tumors, muscles or other tissues. Usually, a sensor that detects gamma rays emitted from a subject who has been administered systemically or locally with a radioactive sample that attenuates in the body due to positron emission is employed. A sensor for detecting gamma rays can be used for either an extracorporeal or an in-vivo device, but the extracorporeal device, which has a less invasive design, has higher safety for the subject. Examples of embodiments of the configuration and functions of the system will be described in detail below.

  The system 10 employs a scintillation material 20 that converts gamma rays into visible light. The photodetector 21 converts the visible light into an electrical signal. This signal is amplified and processed to measure the captured radioactivity. In an extracorporeal embodiment, the sensor temperature is recorded simultaneously during the measurement of radiation, and the data is recorded in a recording file 80 by the measurement controller or control device 12. The recording file 80 may be used as an input value for executing calculation of a data parameter or a predicted data parameter by a prediction model together with a similar recording file at the previous measurement. The purpose of the recording file 80 is to simply represent data collected from the subject 5 or criteria corresponding to the situation, such as the location of the tumor, conditions, and examination time.

  An example of an embodiment of the system 10 shown in FIG. 1 aims to detect gamma rays emitted from a subject 5 (not shown) who has systemically administered a radioactive specimen that is attenuated in the body by positron emission. The system 10 includes one or a plurality of measurement sensors 11 (or a device that detects radiation), one measurement control device 12, one optional processing station 70, and an optional database 75. The The communication line 7 connects a data report or other communication network to a network or the Internet 77 by wired or wireless communication depending on the application. System 10 can include visual, audible, or other means of indicating the status of the injected radiological specimen, including the potential for extravasation after injection.

  From FIG. 2, the measurement sensor 11 includes a sensor housing 25 (not shown), a scintillation material 20, a photodetector 21, a temperature sensor 36, a signal amplifier 33, a sensor processor 22, a non-transient sensor memory 30, and The sensor power supply device 32 is configured. The photodetector 21, temperature sensor 36, signal amplifier 33, sensor processor 22, sensor memory 30, and sensor power supply device 32 can be linked to each other by a wire, a trace circuit, or the like.

  As shown in the exploded view of FIG. 3, the scintillation material 20 and the photodetector 21 can be installed or arranged inside the housing 25 so that they can be used depending on the application. The sensor housing 25 is made of metal (for example, nickel, copper, brass, bronze, steel, aluminum, white, beryllium copper, etc.) or plastic (PE, PP, PS, PVC, ABS, etc.) and is used for the sensor. The housing 25 can also have a light shielding property to protect the scintillation material 20 and the photodetector 21 from natural light or ambient light. Optionally, the sensor housing 25 may define an outer surface and the outer surface may be coated with a light shielding coating. The sensor casing 25 can also protect internal components from environmental deterioration such as exposure of the scintillation material 20 to high humidity. The sensor housing 25 may incorporate or include a shielding mask 38 or shield from associated radiation, such as in vitro detection of gamma rays. The shielding mask 38 is made of iridium, platinum, tungsten, gold, palladium, lead, silver, molybdenum, copper, nickel, bronze, iron, steel, zinc, titanium, aluminum, and the like. As shown in FIGS. 57 and 58, in any embodiment, the sensor housing 25 can include a configuration for alignment and alignment of the backscattering material.

  In use, as shown in FIGS. 4A to 4C, in the embodiment of the sensor housing 25, an adhesive 25 </ b> A adapted so that the housing can be detachably attached to the skin of the subject 5 may be employed. Optionally, the system 10 may employ a removable measurement sensor carrier 35 that is compatible with the measurement sensor 11. The measurement sensor carrier 35 may employ, as part of the carrier surface, an adhesive 35A that is adapted so that the measurement sensor carrier 35 can be detachably attached to the skin of the subject 5 (not shown). Optionally, the measurement sensor carrier 35 defines or employs one or more alignment features 35F that enable repeated alignment with the subject. For example, as shown in the embodiment, the measurement sensor carrier 35 has two alignment functions capable of aligning a marker for marking a mark or a dot on the skin of the subject 5. When performing repeated inspections, the measurement sensor carrier 35 is placed at a position where the mark on the skin of the subject 5 can be aligned with the position alignment function 35F in order to ensure that the measurement sensor 11 is in an appropriate position. May be installed. The measurement function 35F has a variety of approaches depending on the application, such as a temporary marking, a pad capable of edge contouring and orientation marking. Further, embodiments of the sensor housing 25 can include other means for attachment to the arm band 78 for attachment to the arm of the subject 5. The armband may include a hook-and-loop fastener 79 or other means for fixing to the subject 5. One embodiment can include other means for securing the sensor 11 to a pocket or armband.

  The sensor power supply 32, or other power supply described below, is power generation by a battery, wired power connection, transformer, or other type or energy source. In the embodiment, the sensor power supply device may be an electronic / mechanical micromachine adapted to generate electricity from the subject 5 using the dynamics or blood pressure of the subject 5.

  A scintillation material 20 adapted to receive a certain level of gamma rays from a radioactive specimen in the body and emit photons according to or corresponding to the level of the gamma rays can be placed in the gamma ray bundle. The photodetector 21 is adapted to convert the photon multiplied with respect to the level of the gamma ray into signal data corresponding to the photon, and is arranged, installed or arranged with respect to the scintillation material 20. Depending on the application, a mechanism or structure that can direct light directly from the scintillation material 20 to the photodetector 21 such as an optical fiber, a prism, or a reflector is considered necessary. Optionally, as shown in FIG. 3, the photodetector 21 has an active portion 21A that can sense or accept the light expressed here to improve efficiency and reduce the effects of background signals or stray light. The scintillation material 20 can be set and shaped so that it fits well into the part.

  The scintillation material 20 is selected or adapted for use in detecting radiation. As an embodiment of gamma rays, scintillation material 20 is made of bismuth germanate, gadolinium silicate oxyorthosilicate, cerium activated lutetium oxyorthosilicate, cerium activated yttrium oxyorthosilicate, sodium iodide, thallium activated sodium iodide, polyvinyltoluene. And a group consisting of cadmium zinc telluride and the like.

  The measurement sensor 11 includes a signal amplifier 33 adapted to amplify signal data, a sensor memory 30 including a measurement sensor identifier 16 (FIG. 6), and at least a single sensor output for communication and amplification of signal data. The output port 27 is configured. Depending on the required communication mode, the sensor output port 27 is a wide variety of ports such as a power outlet, computer communication (for example, CAT-5), optical communication, infrared communication, and radio wave communication.

  In the embodiment of FIGS. 5A to 5C, the control device or the measurement control device 12 of the system 10 can be linked with each other by a wired circuit, a trace circuit, etc., a control processor 42, a non-transient control memory 40, a control power supply. It comprises a device 52 and a clock 48. The measurement control device 12 can have a control input port 47 that works in conjunction with a sensor output port 27 (not shown), and is adapted to receive amplified signal data from the measurement sensor 11. Interlocking includes wired or wireless communication of a wide variety of communication protocols. For example, the control input port 47 can be linked to the sensor output port 27 or wireless communication by a cable (for example, the multiconductor cable 24) or a trace circuit. Furthermore, in addition to the amplified signal data, other data or information such as operating parameters, power storage, device operation indications or other sensor data may be communicated between the measuring sensor 11 and the measuring control device 12. It may be desirable. Optionally, the measurement control device 12 may include a screen 44 and a data input device 45 such as a touch screen or other input / output structure. The embodiment can include a control device or measurement control device 12 and one or a plurality of sensors 11 housed and interlocked in the same housing.

  The control memory 40 includes control computer program code 56 (FIG. 6) that can be executed by the control processor 42. For example, the control computer program code 56 includes a first module 61 for executing a measurement function and a second module 62 for data management. For example, the first module 61 receives the previously used sensor identifier 16 for measurement (described below), signal data, subject identifier, etc., and records the signal data, sensor identifier, sensor identifier 16 for measurement, etc. Fits up to 80 formats. The second module 62 is adapted to receive the signal data of the recording file 80 from the first module 61 and transfer the correction signal data to a predetermined storage device. Such storage devices include local memory (eg, sensors or controls), external memory, remote computer memory, network memory (wired or wireless), or memory accessible via the Internet.

  The system 10 has a temperature sensor 36 that is paired with a temperature sensor 36 and is adapted to measure the ambient temperature within the system 10 and communicate the ambient temperature to the temperature corrector 50. Accordingly, the temperature corrector 50 is adapted to calculate a temperature correction index based on the result of comparing the reference temperature and the ambient temperature. As described below, the measurement sensor 11 may include temperature-sensitive components. The temperature corrector 50 is adapted to generate temperature correction signal data using a temperature correction index for the signal data. In embodiments that sense in the body, temperature correction may not be necessary. Further, some embodiments of the present system 10 may include temperature response calibration means that negate the effect of temperature on the operation of the system 10. This invalidation can be accomplished by measuring the response of sensor 11 to temperature and then modifying the parameters of amplifier 33 or other circuit components to cancel this temperature response.

  Optionally, as FIGS. 7-8 and FIGS. 29-33 show, embodiments of the measurement sensor 11 may include an internally processed light shield 28. In an example of such an embodiment, the printed circuit board unit 23P may be a substrate 23 having a first surface 23A and a second surface 23B on the opposite side. The light shielding body 28 is adapted to shield the scintillation material 20 and the photodetector 21 from ambient light, and is placed on the first surface 23A of the substrate 23. The scintillation material 20 and the photodetector 21 may be covered or surrounded by the light shielding body 28. For example, since the first width of the scintillation material 20 and the second width of the photodetector 21 are parallel to the surface, the light shielding body 28 has the scintillation material 20 contained in the first cavity 28A and the second cavity 28B. In order to accommodate the photodetector 21, the first cavity 28A is adapted to be defined as a third width equal to or greater than the first width, and the second cavity 28B is defined as a fourth width equal to or greater than the second width. When the first cavity 28A and the second cavity 28B communicate with each other and the scintillation material 20 is accommodated in the first cavity 28A and the photodetector 21 is accommodated in the second cavity 28B, the light shielding body 28 is composed of the scintillation material 20 and the photodetector 21. May be located proximally to allow optical alignment. When these components are placed on the printed circuit board unit 23P, they can be linked. For the purposes of this section, the term “width” means an effective width that allows the described storage and is not intended to be a specific cross-sectional shape. That is, the term “width” is intended to allow storage of parts as described and is not limited to the cross-sectional shape of each interaction. In an example of an embodiment of the light shield 28, the light shield seal 81 can be used to seal the cavity after the scintillation material 20 and photodetector 21 are assembled. The light-shielding sealing material 81 is, for example, epoxy, caulking, or potting composite material.

  Such a light shield 28 is made of metal (eg, copper, brass, bronze, iron, aluminum, nickel silver, beryllium copper, silver, gold, nickel, etc.) or plastic (eg, ABS, acetal, acrylic, fluororesin, From raw materials selected from polycarbonate, nylon, vinyl chloride, polypropylene, polystyrene, polyethylene, etc.). Optionally, the light shield 28 may be plated or applied to a single material so that it can be soldered or placed on the printed circuit board unit 23P.

  When the light shield 28 is processed with metal, metal clad or plated plastic, it is fixed to the printed circuit board unit 23P with leaded or lead-free solder as a surface mounting component, or a part of the light shield 28 as an insertion mounted component Penetrates the hole in the circuit board and closes the hole with solder. When the light shield 28 is made of plastic, a part of the light shield 28 is fixed as a snap-type component by a spring when it penetrates the hole of the printed circuit board unit 23P, and is prevented from coming out of the hole or as a swage type component. Melt or swage so that the part of the body that penetrates the hole does not come out of the hole. Furthermore, the light shield 28 has a wired connector and can be placed so that it can be removed from the printed circuit board.

  Optionally, the light shield 28 has one or more through holes for equalizing pressure or venting during assembly. These holes are covered with a light-shielding foil tape or a sealing material 81, if possible, so as to be a shield that can block light after assembly.

  As shown in FIG. 7, the light shield 28 has a light emitter 31 (e.g., LED, light bulb, semiconductor laser, etc.) so that the light emitter can inspect the photodetector 21 by generating pulsed light within the housing of the light shield 28. ) May be encapsulated. Thus, the system 10 includes a light emitter 31 that is associated with the sensor power supply 32, and is adapted to allow the light shield 28 to receive the light emitter 31 proximate the photodetector 21, the light emitter 31 being the first cavity 28A. Alternatively, it is disposed in the second cavity 28B (or a cavity adjacent to them).

  In some embodiments, the control computer program code 56 further includes a third module 63 adapted to receive data stored in the recording file from the second module 62. As a prediction result, the third module 63 uses the stored data as a prediction model in order to generate prediction data for a predetermined period in the recording file, or communicates the prediction result to a predetermined storage device. Sometimes. In another embodiment, the third module 63 uses the stored data or calculates the prediction result corresponding to a predetermined storage device in order to calculate the transition of the corrected communication data in the predetermined period in the recording file. Sometimes communicate. In another embodiment, the third module 63 utilizes the stored data or communicates the prediction result to a predetermined storage device in order to calculate the transition of the corrected communication data in the predetermined period in the background data. Sometimes. The background data is obtained from the second measurement sensor 11, the previously calculated background radiation level, or a separate radiation sensor, depending on the application. In another embodiment, the third module 63 uses the stored data to calculate the quality of the radiological sample injection, such as monitoring the change in the corrected signal data or calculating the possibility of extravasation of the injection. Fit to be able to. The result can be transferred to a screen and / or a predetermined recording medium. Thus, the user can be warned or notified of the state by any of visual, audible, or other instruction means.

  FIG. 24 shows the height or output of the radiation pulse count over time indicated by the arm sensor 11 injected when the radiological sample is properly administered, and is the low level region 88 before the injection, Spike 89 and low level region 90 after injection. This signal data indicates a particular parameter pattern (ie, amplitude, slope, time) that is characteristic of proper radiological sample administration. The low level region after injection following spike 89 at the time of injection indicates that the radiological specimen has been resolved by proper administration or injection. FIG. 25 shows simultaneously the output 91 from the injected arm sensor 11 due to an improperly administered radiological specimen (ie extravasation or exudation) and the low level region 92 of the non-administered arm. In general, the timing 93 at which the PET scan is performed shows a very high count or amplitude value. FIG. 26 also shows the output 94 from the injected arm sensor 11 from another improperly administered radiological specimen (ie extravasation or exudation) and the low-level region 95 of the non-administered arm simultaneously. As shown, at timing 96 when a normal PET scan is performed, a generally normal low level count or height (estimated from valid measurements, dotted line) is shown. From these, improper dosing parameter patterns and data characteristics are distinguishable compared to the proper dosing parameter patterns and data. Other than this approach, the clinician cannot detect inappropriate dosing. In addition to extravasation or exudation, even seemingly normal radiological resolution, improper dosing lurks or is characterized by other inaccuracies (eg, protocol deviations).

  In some embodiments, the system 10 may include a processing station 70 (FIGS. 1 and 9). The processing station 70 may be a computer that communicates with the measurement control device 12. Embodiments of processing station 70 may include a station processor, a non-transient station memory, a station processor with which the station power supply is interworking, a non-transient station memory, and a station power supply. The processing station 70 may have a station input port operatively associated with the control output port and adapted to receive data from the measurement control device 12. In some embodiments, the roles of the measurement control device 12 and the station 70 may be integrated.

  Similar to the measurement control device 12, the processing station 70 can be executed by the station processor, receives the storage data of the recording file from the second module 62, and uses the prediction data in the recording file for a predetermined period as the prediction result. In order to generate, it may include station computer program code 76 that includes a third module 63 adapted to utilize the stored data in a predictive model.

  Optionally, the processing station 70 may include a storage device 71 for the measurement control device 12. The storage device 71 may be interlinked with the station processor. The storage device 71 is adapted to receive the measurement control device in the form of a cage, a fixture, a refiller or a gantry. When the measurement control device 12 is stored, the storage device 71 may provide the measurement control device 12 with an electrical connector that can execute data communication and power exchange. In one example embodiment, the third module 63 is adapted to calculate the quality of the injection of the radiological specimen by modeling such as identifying specific changes or calculating the likelihood of extravasation of the injection. The station computer program code can then transfer the calculation result to a predetermined recording medium. Furthermore, the station computer program code can alert the user of the calculation result using visual, audible or other indicating means.

  In some embodiments, the prediction model may be a classification machine learning model. In other embodiments, the prediction model may be an unsupervised population analysis. Such unsupervised population analysis or other predictive models are adapted to predict future outcomes, predict tumor treatment effects, and predict transfer.

  In some embodiments, a plurality of measurement sensors 11 may be used. For example, the system 10 includes first and second measurement sensors 11, which are administered systemically or locally to a subject, and positron emission is attenuated in the body near the examination site. Suitable for detecting laboratory gamma rays emitted from radioactive specimens. The second measuring sensor is adapted to detect a test gamma ray emitted from a radioactive specimen that is administered systemically or locally to the subject and whose positron emission is attenuated in the body near the background site. Depending on the application, the computer program code 56 for control or the computer program code 76 for the station can receive the stored data of the recording file of the second module 62 including the data from the first and second measurement sensors 11, and can receive the second measurement data. A fourth module 64 adapted to be able to subtract the signal data of the sensor 11 from the signal data of the first measuring sensor 11 may also be included. In other applications, the fourth module 64 can receive the stored data of the recording file of the second module 62 including the data from the first and second measurement sensors 11, and the signal data of the second measurement sensor 11 can be received as the first data. A fourth module 64 adapted to be subtractable from the signal data of one measuring sensor 11 may also be included. This embodiment can allow for subtraction of background radiation from sensor data. Furthermore, the embodiment can estimate the likelihood of extravascular leakage in systemic or local radiological injections.

  In some embodiments, the signal data may be multiple pulses at a pulse frequency over time. The first module 61 is adapted to communicate to the sensor processor 22 an indication of the sampling frequency that is a function of the pulse frequency of the signal data. In some embodiments, the first module 61 is adapted to increase the sampling frequency indication as the pulse frequency increases.

  As one aspect of this approach, the apparatus includes a measurement sensor 11 having a casing 25, a scintillation material 20, a photodetector 21, a light shield 28, a temperature sensor 36, a signal amplifier 33, a sensor processor 22, and a non-transient sensor memory. 30 and a sensor or a device that detects radiation, which is composed of the sensor power supply device 32. In some cases, the photodetector 21, the temperature sensor 36, the signal amplifier 33, the sensor processor 22, the sensor memory 30, and the sensor power supply device 32 can be linked via the printed circuit board unit 23P. The printed circuit board unit 23P is a flat surface and may be defined as a substrate 23 having a first surface 23A and a second surface 23B on the opposite side. In some cases, the light shielding body 28 can block the scintillation material 20 and the photodetector 21 from ambient light by being adapted to be placed on the first surface 23A of the substrate 23. The scintillation material 20 and the photodetector 21 may be covered or surrounded by a light shield 28. For example, since the scintillation material 20 has a first width parallel to the plane, and the photodetector 21 has a second width parallel to the plane, the light shielding body 28 has the first cavity containing the scintillation material 20. The first cavity 28A has a third width greater than or equal to the first width, and the light shield 28 is further adapted to accommodate the second cavity in the second cavity 28B, and the fourth width of the second cavity 28B. May be greater than or equal to the second width. When the scintillation material 20 is accommodated in the first cavity 28A and the photodetector 21 in the second cavity 28B, the light shielding body 28 aligns the scintillation material 20 and the photodetector 21 with each other in the first cavity 28A and the second cavity 28B. It may be linked and adjacent so that it can. When the component is placed on the printed circuit board unit 23P, the function may be linked.

  The scintillation material 20 is adapted to receive gamma rays and emit photons corresponding to the amount of the gamma rays, and the scintillation material 20 and the photodetector 21 are disposed in the light blocking body 28. The photodetector 21 is adapted to receive the multiplied photons and convert them into signal data corresponding to the amount of radiation, and is arranged with respect to the scintillation material 20.

  As described above, the signal amplifier 33 is adapted to amplify the signal memory, the sensor memory 30 including the sensor identifier for measurement, and the measurement memory having at least one sensor output port 27 for the amplified signal data. Optionally, the light shield 28 may be placed on the first surface 23A of the plate with solder. In some embodiments, the light shield 28 is selected from metals such as copper, brass, bronze, steel, aluminum, nickel silver, beryllium copper, silver, gold and nickel.

  In one aspect of the present system 10 for detecting gamma rays emitted from a subject, at least a single measurement sensor 11 is for a sensor made of a biocompatible material that can be sealed, as shown in FIGS. 10A and 10B. There may be a case 25, a scintillation material 20, a photodetector 21, a signal amplifier 33, a sensor processor 22, a non-transient sensor memory 30, and a sensor power supply device 32. In some cases, the photodetector 21, the signal amplifier 33, the sensor processor 22, the sensor memory 30, and the sensor power supply device 32 can be linked to each other by wired communication, a trace circuit, mutual wireless communication, or the like. Optionally, the biocompatible material of the sensor housing 25 is categorized as glass, polyether ether ketone, ultra high molecular weight polyethylene, etc., for applications such as conforming to internal implant standards. Material selected. As a further option, the sensor housing 25 may have a fixture 25F so that it can be secured to a site intended for inspection or sensing for external use.

  Similar to what was described above with reference to FIG. 3, the photodetector 21 has an active portion 21A, and the scintillation material 20 can be configured to substantially match the active portion 21A. The scintillation material 20 and the light detector 21 are adapted so that the scintillation material 20 is exposed to a certain amount of gamma rays from the radiation specimen in the body and emits photons according to the gamma dose, and the light detector 21 is applied to the scintillation material 20. On the other hand, the photon multiplied according to the gamma dose may be received and adapted to be converted into signal data, and may be disposed in the sensor housing 25. The signal amplifier 33 is adapted to amplify signal data. The sensor memory 30 may include the measurement sensor 11 having at least one sensor wireless output port 27 for the measurement sensor identifier 16 and their amplified signal data.

  As an example of the embodiment of the measurement sensor 11, the measurement sensor 11 may be linked to an external measurement control device 12 having a control processor 42, a non-transient control memory 40, a control power supply device 52, and a clock 48. Similar to that described above with reference to FIGS. 5A-5C, the control processor 42, the control memory 40, the control power supply 52, and the clock 48 are interconnected in a wired communication, trace circuit, or other communication method. There may be. The measurement control device 12 may have a control wireless input port 47 that is operatively coupled to the sensor wireless output port 27 and adapted to receive the amplified signal data from the measurement sensor 11.

  The control memory 40 may include control computer program code or software 56 that can be executed by the control processor 42 (FIG. 6). Such control computer program code or software 56 may include a first module 61 for measurement and a second module 62 for data management. The first module 61 receives the measurement sensor identifier 16, the amplified signal data, the subject identifier, and relates the signal data, the sensor identifier 16, and the measurement sensor identifier in the format of the recording file 80. Fit as you can. The second module 62 is adapted to receive the amplified signal data of the recording file 80 from the first module 61 and to transmit the amplified signal data to an arbitrary recording medium.

  Optionally, the system 10 is for in-body measurement with a substantially cylindrical sensor housing 25 defining an outer surface 25S of the sensor housing and a length 25L of the sensor housing (FIG. 10B). A sensor 11 may be included. In some such embodiments, the sensor wireless output port 27 may have an antenna and associated transmitter generally along the length 25L of the sensor housing 25. Nearly along the length is simply a general location or most of its length, but need not be a full length or a straight antenna. For example, the sensor output port 27 embodiment may be a coiled antenna along a portion of length 25L, as shown in FIGS. 10A and 10B. The fixing tool 25F may surround all or part of the circumference of the sensor casing 25, and may be composed of a round rod that overlaps at least one round (key holder ring). The round gob or fixture 25F that overlaps at least one round is arranged on the outer surface 25S, and the height from the outer surface is 0.1 to 3.3 so that the sensor housing 25 can be fixed at a predetermined position. There may be 0 mm. Other fastener 25F embodiments may have functions such as adhesion, ridges, protrusions, or eyelets that can minimize movement relative to the patient or subject 5. The sensor housing 25 may have other general shapes.

  In one example of such an embodiment, the computer program code or software 56 optionally further receives stored data from the recording file 80 from the second module 62 and uses the stored data as a recording file as a recording file for a predetermined period. A third module 63 may be included which is used in a prediction model that can calculate the predicted data value of the first and second data and is adapted to transmit the prediction result to a predetermined recording medium. As another option, the computer program code or software 56 receives the stored data from the recording file 80 from the second module 62, calculates the transition of the signal data amplified in a predetermined period, and transfers the transition to a predetermined recording medium. It may also include a third module 63 that can transmit. As another option, the computer program code or software 56 receives the stored data from the recording file 80 from the second module 62, calculates the transition of the amplified signal data relative to the radiation background data in a predetermined period, It may include a third module 63 adapted to send the transition to any recording medium. In some embodiments, this third module is adapted to calculate the quality of the injection of the radiological specimen, such as calculating the likelihood of extravasation of the injection. The computer program code can then transfer this calculation result to a predetermined recording medium. Furthermore, the computer program code can alert the user of the calculation result using visual, audible or other indicating means.

  In one example embodiment, the signal data is composed of a plurality of pulses at a temporal pulse frequency so that the first module 61 indicates to the sensor processor 22 a sampling frequency that is a function of the pulse frequency of the signal data. Fit to be able to communicate. The first module 61 is adapted to increase the communication of an indication of the sample frequency as the pulse frequency increases.

  Most of the processes for manufacturing components such as the measurement sensor 11 are general processes in the manufacture of electronic devices, but include the following specific processes. For example, as an example of an embodiment of the present system 10 that includes a gamma ray shielding mask or shield 38, the mask or shield 38 may be glued, molded, crimped, screwed, or otherwise attached to the measurement sensor housing 25. May be fixed mechanically. Therefore, the mask or shield 38 may be used as a mounting plate for other components of the measurement sensor 11 including an electrical component and a casing component for manufacturing the light-shielding casing 25. As shown in FIGS. 57 and 58, in any embodiment, the sensor housing 25 can include a configuration for placement and alignment of the backscattering material 82.

  In another example embodiment, the components of the measurement sensor 11 are placed in the measurement sensor housing 25 and then coated with epoxy, silicon or other curable liquid around it. In some cases. In this method, the optical components can be fixed in an aligned state while being surrounded by a light shielding material.

  In another example of the embodiment, the measurement sensor 11 including the wireless output port 27 as an antenna may be incorporated in the structure of the measurement sensor housing 25. For example, the antenna wire may be placed on a molded product, and the wire may be encapsulated by molding plastic around the antenna wire. In this way, the antenna lines can be of a wide variety of designs to optimize antenna efficiency. Furthermore, this method also allows a ferrite material to be installed in the antenna portion of the housing 25 in order to further optimize the antenna efficiency.

  Additional aspects or optional embodiments are shown below. The current system has a sensor that detects radiation outside the body, such as on or near the subject's skin, although it is not essential. These sensors can measure the local absorption of the radiolabeled tracer administered to the subject 5. In the embodiment shown in FIG. 1, the measurement sensor 11 has one or more sites shown in FIG. 11, for example: (1) directly above the tumor 1; (2) the right upper arm 2 approximately 10 cm proximal to the antecubital fossa (3) Left upper arm 3 approximately 10 cm proximal to the anterior elbow. (4) Can be placed directly above the liver just below the sternum or just below the nipple. As shown in FIG. 2, in an example of the embodiment of the system 10, for example, 1) one or more measurement sensors 11; 2) one measurement control device 12; 3) measurement and prediction value calculation or injection It may consist of computer software or program code 13 that can perform functions such as evaluation of the possibility of extravasation. The system 10 may include a predetermined storage device for data having an appropriate database, database management or server management software 14 or the like.

  As shown in FIGS. 14 to 16, the measurement sensor 11 is necessary for, for example, the interaction of the scintillation material 20, the photodetector 21, the non-transient sensor memory 30, the logic or sensor software 26, and these components. One sensor processor 22 having a circuit, and optionally a printed circuit board 23P, can be constructed. For example, FIG. 17 illustrates the operation of an embodiment of the external measurement sensor 11 in a block diagram. In operation, the subject 5 is administered a radioactive substance (also called a tracer) systemically or locally. As this radioactive material decays, it emits or emits positrons (also called high-energy particles). The measurement sensor 11 receives gamma rays due to positron emission attenuation using the scintillation material 20, and detects the light by converting the radiation into photons such as a pulse wave of light. The sensor processor 22 can measure and collect photons based on the number of optical pulse waves detected in a certain period. For example, when a large number of light pulse waves are detected within a certain period, this corresponds to a high concentration of radioactive material. As the concentration of the radioactive substance changes, the number of optical pulse waves within a certain period changes following the change. When the data collection time and the number of light pulse waves are graphed, the radioactivity concentration over time can be visually shown. This graph can show how the radioactivity concentration changes. As an option, the noise reduction unit 37 (FIG. 14) may include a filter that filters the amplified signal data based on the height or amplitude of such pulses. For example, the noise reduction unit 37 can include a voltage comparator or analog-to-digital converter having computer program code that compares the digital output to a reference level.

  The measurement sensor 11 can adopt a small non-specific built-in processor, and the processor for the sensor is necessary for the application, and when there is no external type in other circuits, an asynchronous dedicated counter of an appropriate size is used. Can be included. The sensor processor 22 may be a built-in sensor sensor or an external sensor processor 22 depending on the application. The sensor processor 22 can be configured to accommodate each of a wide variety of embodiments of the system 10. For example, an FPGA or other programmable logic device is well suited as such a system, such as by incorporating a microprocessor subsystem into the FPGA design.

  Without limitation, bismuth germanate (BGO); gadolinium oxyorthosilicate silicate (GSO); cerium activated lutetium oxyorthosilicate (LSO); cerium activated lutetium yttrium oxyorthosilicate (LYSO); thallium activated sodium iodide (NaI (T1)); Plastic scintillator (polyvinyl toluene); or cadmium zinc telluride (CZT) or the like is the scintillation material 20. Embodiments of the measurement sensor 11 may use a plurality of scintillation materials 20 adapted to measure different radioisotopes. In another embodiment of the measurement sensor 11, a scintillation material 20 that does not require the photodetector 21 can be used. In another embodiment of the measurement sensor, a plurality of scintillation materials 20 having individual detection circuits can be used so that a two-dimensional array can be measured.

  In an example embodiment of the measurement sensor 11, the photodetector 21 may include a signal amplifier 33 or an amplifier circuit so that low level signals can be processed. In other embodiments, the measuring sensor includes a pair of temperature compensators 50 that communicate or report their temperature with a temperature sensor 36 adapted to measure the ambient or local temperature of the scintillation material 20 and the photodetector 21. May have. The temperature corrector 50 is adapted to calculate a temperature correction coefficient by comparing the reference temperature and the ambient temperature. The temperature corrector 50 is adapted to calculate signal data that has been temperature corrected using the correction coefficient as signal data, or to notify the local temperature of the scintillation material 20 and the photodetector 21. In some embodiments, since the measurement sensor 11 is in-vivo detection, it is calibrated to the normal body temperature of the subject, and thus temperature correction may not be required. In addition, some embodiments of the measurement sensor 11 can include a temperature response calibration function, which will negate the effect of temperature during operation of the system 10. This invalidation can be achieved, for example, by measuring the response of the sensor 11 to temperature and then modifying the parameters of the amplifier 33 or other circuit components to cancel the temperature response.

  In another example embodiment of the system, the measurement sensor 11 is, for example, a scintillation material 20, a photodetector 21, an associated signal amplifier 33 or an amplification circuit disposed on a printed circuit board 23P in the sensor portion of the system. And a sensor processor 22. The photodetector 21 can select a photodiode or a photocathode according to the application, and the signal amplifier 33 (or an amplifier circuit incorporated in the printed circuit board 23P) includes a photomultiplier tube or simply the signal amplifier 33 only. There are cases. In that case, other related circuits are included in the measurement control device 12. In any embodiment, the measurement sensor 11 may have a power generation capability by a micromachine (MEMS), and thus may not require a battery or an external power source. The MEMS generator is adapted to be able to generate power based on body movement, body temperature or blood pressure of the subject 5 based on piezoelectricity. The sensor power supply device 32 may be supplied with power by being connected to a control device or the like. In another example of the embodiment, the measurement sensor 11 may be supplied with power from an independent sensor power supply device 32 by wireless communication.

  In an example of the embodiment of the measurement sensor 11, for example, the electronic device is enclosed in a light-shielding housing or the housing 25, and data communication is enabled by the multiconductor cable 24. Due to the mechanical design of the housing 25, the scintillation material 20 can be arranged at an accurate position. As shown in FIGS. 57 and 58, in any embodiment, the sensor housing 25 can include a structure for placement and alignment of the backscattering material 82.

  In one example embodiment of the measuring sensor 11, a shielding mask 38 that optionally allows collimation of incident radiation to improve azimuth sensitivity, or a rear for reflecting incident radiation that is not captured by the scintillation material 20. The scattering material 82 may be employed. The shielding mask 38 is made of the following high-density materials: lead, steel, iron, aluminum, iridium, platinum, copper, cement, high-density plastic, and the like, although not limited thereto. The shielding mask 38 can be adjusted to protect against specific radiation depending on the application of the system of the present invention. As described above, the sensor housing 25 may include a structure for arranging and aligning the backscattering material 82.

  In the embodiment of the measuring sensor 11, for example, the sensor can also include a removable sleeve or a case, referred to as a carrier 35, which can be removed and disposed. In some cases, the sleeve or carrier 35 can be bonded (for example, an adhesive 35 </ b> A) so that the measurement sensor 11 can be attached to the subject 5. The sleeve can also be used as a sanitary barrier between the measurement sensor 11 and the subject 5. In some embodiments, the measurement sensor 11 may include a housing 25 having an adhesive to which the sensor 11 and the subject 5 can be attached. Some embodiments of the sensor 11 can include a structure for attachment, such as an arm band for attachment to the arm of the subject 5. Such an armband can include a hook-and-loop fastener or other means for securing to the subject 5. In certain embodiments, it may include a pocket or other structure by which the sensor 11 is secured to a mounting structure or armband.

  In any embodiment, the measurement sensor 11 and the measurement control device 12 may have hardware and software that enable wireless communication with each other. In such embodiments, encryption techniques may be used to protect the wireless signal.

  In any embodiment of the system of the present invention, the measuring sensor can be individually calibrated for radiation sensitivity. The calibration can calibrate measurement discrepancies due to sensor manufacturing and physical tolerances. Since manufacturing and physical tolerances and material properties of the measuring sensor 11 are individually different, it is a well-known fact that each sensor does not show the same measured value even when input from the same radiation source. Thus, each sensor can calculate a correction factor from known radiation source activity. As a result, each measurement sensor 11 used in the system 10 can mutually correct for radiation sensitivity.

  In any embodiment, the measuring sensor 11 can be individually calibrated for temperature sensitivity. The components used in the measurement sensor 11 are sensitive to changes in temperature and radiation levels due to temperature. For example, it is known that the scintillation crystal or material 20, the photodetector 21, and the amplifier used to detect the light are also somewhat temperature sensitive. Therefore, a highly accurate temperature sensor 36 may be installed locally or proximally in the temperature sensitive part. This allows the ambient temperature to be recorded during the data collection process so that it can be corrected or corrected to signal data or measurement values, thereby correcting any errors in the measurement values that may be caused by temperature sensitive parts, and temperature corrected signals. Data can be calculated. In order to obtain the temperature correction coefficient, the ambient temperature is changed within the operating temperature range with respect to the radioactive inspection source in which the measuring sensor 11 is stable. This can be done in an inspection temperature chamber. The test records radioactivity and temperature data from a known stable source. This allows the calculation of a calibration curve that adjusts the measured radioactivity corresponding to the expected corrected signal data to a normalized flat response. Further, some embodiments of the sensor 11 can include temperature response calibration, which can negate the effect of temperature during system operation. Invalidation can be achieved by measuring the response of sensor 11 to temperature and then modifying the parameters of amplifier 33 or other circuit components to cancel this temperature response.

  In another example embodiment, measurement sensor 11 may provide adaptable performance and measurement capabilities. For example, if the tumor growth rate accelerates, the sensor can automatically increase the sampling frequency in response to this change.

  In any exemplary embodiment of the system, the measurement control device 12 is, for example, a hand-held battery-powered device having a screen, a keypad, and a data communication terminal. In an alternative embodiment, the measurement control device 12 can include one or more sensors 11 housed in the same housing and linked by wiring, trace lines, or the like. In an example of an embodiment that can replace the system of the present invention, the measurement control device 12 is a desktop-type external power supply device. In another example embodiment, the measurement control device 12 or other component of the system 10 may have a cradle-shaped charging dock for battery powered devices. A cradle-type charging dock can also charge a handheld device or initiate the transfer of measured data in the memory of the handheld device. In another example embodiment, the measurement control device 12 may have a MEMS power generation function that does not require a battery or an external power source.

  In any embodiment of the system 10, as shown in FIGS. 20 to 21, for example, the measurement control device 12 includes a control processor 42, control software 56 (optionally may be built-in software), control Memory 40, real-time clock 48, and other related logic and circuitry may be included on the printed circuit board. The control processor 42 may be embedded in the control control device 12, provided as an external processor, or optionally combined with the station 70. The control processor 42 is specially configured to satisfy many of the system 10 embodiments. The control device controls operations such as user interface, data collection, and data communication. There are various types of microprocessors that can realize this, such as a small internal processor and a single board computer. FIG. 21 is a flow diagram illustrating the operation of the embodiment of the measurement control device 12. The system 10 generally responds to the transfer of measurement data to a predetermined recording medium, such as user input, sensor sticking or related tracking, monitoring of operating parameters such as battery level, and an external computer. In an embodiment of the measurement control device 12, for example, as shown in FIG. 20, a plurality of data communication so that a plurality of measurement sensors 11 can be connected and data communication with a wide variety of predetermined recording media and networks can be performed. May have a terminal for use.

  In one example embodiment of the measurement control device 12, the device may additionally have control hardware and software that incorporate the functionality of network connectivity and control computer software 56. Thereby, the independent system which does not require another computer and computer software at an inspection place can be constructed | assembled. State-of-the-art encryption and cipher reading methods are used to protect wireless communications.

  An example embodiment of the measurement control device 12 may include a barcode reader to record associated identification numbers, correction codes, etc. printed on the barcode. In the embodiment of the measurement control device 12, in order to add additional data to the measurement item, it is possible to add a sensor that can detect the pulse rate, the blood pressure oxygen saturation, the skin resistance, and other biological values. An example embodiment of the measurement control device 12 may include a digital camera system so that a photograph can also be included in the data recording file. These photographs can be used, for example, for detailed installation positions of the sensors. Embodiments of the measurement control device 12 may include a function that can communicate to the user specific content related to the subject under test or the test itself. This communication includes, but is not limited to, an installation position outside the reference of the measurement sensor 11, notification of the tumor size and location, general annotations, photographs related to the examination, and the like.

  In an example of the embodiment of the measurement control device 12, for example, the power switch can centrally manage the power supplies of all the components of the device other than the real-time clock 48. The clock 48 may have persistent reserve power to prevent loss of programmed date and time. When the power switch is “on”, power is supplied to the components of the instrument and the microprocessor can start and perform a functional check. The microprocessor of the control processor 42 may also check external peripheral devices such as the screen 44 and the real time clock 48. During the inspection, for example, a standby message can be displayed on the screen of the measurement control device 12. Next, at least one measurement sensor 11 is connected to the control device 12 via a connector such as a multiconductor cable 24 and the cable. After connecting the measurement sensor 11, the control device 12 recognizes the connection and performs operations necessary for starting the measurement sensor 11.

  In an example of the embodiment of the measurement sensor 11, for example, power to the sensor may be supplied via the measurement control device 12. For example, in order to connect the measurement sensor 11 to the measurement control device 12, a multiconductor cable 24 having a connector or a plug at the end to be fitted may be used. Power can be supplied from the measurement control device 12 to the measurement sensor 11 via this cable. The sensor can be connected to the measurement control device 12 before data collection, and the connection can be maintained during data collection. In another example embodiment, the measurement sensor 11 does not need to be connected to the measurement control device 12 during operation, and the measurement sensor 11 has its own sensor power supply 32 so that no cable is required for data storage. And a non-transient sensor memory 30. Depending on whether the wireless communication is enabled or connected to the measurement control device 12 with a cable, the recorded data can be acquired when necessary.

  When the sensor 11 is turned on, for example, as shown in FIGS. 17 and 21, the sensor processor 22 is started and self-inspection can be started. When it is confirmed by the self-inspection that the measurement sensor 11 is activated, the sensor is capable of operating the measurement sensor 11 in the sensor control device 12 and an address necessary for communicating with the measurement sensor 11 recognized by the control device 12. It is possible to warn that it is possible to receive. In response, the measurement control device 12 sends a unique address or identifier 16 assignment to the measurement sensor 11 (e.g., a sufficiently individualized uniqueness depending on the application to avoid confusion). Can do. After receiving the assignment of the unique identifier 16, the measuring sensor 11 can accept a unique address and listen for commands to the individual sensors from the communication bus. The measurement control device 12 can send any of the following commands to the connected sensor: (1) Confirming the connection using the unique address of the sensor; (2) Turning on / off the sensor LED; (3) Setting of sensor PWN output; (4) Reading / writing of sensor EEPROM; (5) Temperature measurement or (6) Radioactive pulse measurement for a predetermined period (for example, 1 second) or both. Other commands not specified can also be transmitted from the measurement control device 12. When a command is transmitted from the measurement control device 12 to the measurement sensor 11, the sensor executes the command and responds as necessary.

  In any example embodiment of the system, if one or more measurement sensors 11 are connected to a measurement control device 12 and the sensor is operable, the measurement control device 12 may, for example, collect data from the device. It can be displayed on the screen as a message that it can start. When the user starts data collection, the measurement control device 12 first downloads the calibration data of the individual sensors, and stores the calibration data in the control memory 40 or a predetermined memory or recording medium. Thereafter, the control device 12 can request measurement of temperature and radioactive pulses from each of the connected measurement sensors 11. All the measured values received can be recorded in the memory 40 for control together with the time stamp. When the control memory 40 is full or the user has finished collecting data, the measurement control device 12 may temporarily stop accepting measurement values from the measurement sensor 11. The user can download the data stored in the control memory to a computer or other predetermined recording medium.

  In any example embodiment, the computer program code used in the system has the following functions: (1) execution of a diagnostic test of the measurement control device 12; (2) transfer measurement data from the measurement control device. (3) Collect test-related data (administered radiation dose, subject weight, PET scan data, etc.) from users and other sources and add to data record file; 4) Transfer the data recording file to the database server management software; (5) Calculate the possibility of improper injection of the radiological specimen and either auditory, visual or other signal to the user Its report or display by. In any embodiment, the database server management software accepts received data from computer software and can apply one or more algorithms to the received data. Measurement data can be stored in an optional central database 75 while creating a user report based on the results of the algorithm. These reports can show estimated parameters for the tumor or even parameters estimated in the future.

  In an example of an embodiment of the present system, for example, a user connects the measurement control device 12 to a computer, and transfers measurement data stored in the measurement control device 12 to the computer using software of the computer. Can do. Computer software or program code communicates with the control device 12 to determine the type and capacity of data that can be downloaded. The computer software can ask the user for additional information related to the examination, such as the dose of radiation administered, the identification or number of the subject 5, the location of the sensor, the location and type of the tumor. As soon as the measurement data is transferred from the measurement control device 12 to the computer, a data recording file can be constructed. Once the data record file is constructed, it can be transferred to a database server, predictive model or algorithm system.

  In any example embodiment, a pre-processing operation can be performed on the subject's data set. For example, session measurements for all channels can be normalized according to the dose of radiation administered. The dose is recorded during the examination and is used to adjust the measurement based on the scalar. A session refers to a specific data recording process including the sensor position of the subject 5, the administered radioactive material, data collection / recording / transfer, and the like. The measured values for each session can be matched so that the trigger channel rising point on the right or left arm is at zero time. A trigger channel refers to a sensor that is known to dramatically and easily recognize an increase in measured value due to the passage of a large amount of radioactive material. Such a clear and steep step-like change makes it possible to adjust the time axis of the recording data set at different times or sessions. Data around the predetermined time (for example, data before -120 seconds or data after 3600 seconds) can be deleted from the measurement data. In addition, session measurements for all channels can be normalized for temperature sensitivity. The temperature correction factor of an individual sensor can be read and used to correct the measured number of radioactive pulses.

  In any example embodiment of the system, the session measurements for all channels can be adjusted to account for the natural decay of the radioactive isotope used, for example. Since radioactive isotopes decay naturally in the body of the subject, it is necessary to add a decreasing function to the measurement data. By taking this natural attenuation into account and removing the data resulting from the natural attenuation, it is possible to achieve the radiation dose encountered that does not include the data attenuation function.

  In any exemplary embodiment of the system 10, the measurements can be matched according to the control channel. Since the control channel is reproducible and stable, the difference between the non-control channels is made visible by matching all the channels.

  In an example embodiment of the present system 10, a database server and a prediction model are presented. These are hardware server and database server management software that executes software that takes a data recording file received from computer software and stores the received data in a dataverse file together with already stored data. For example, FIGS. 14 and 15 show operational flow diagrams of exemplary computer software and database server management software embodiments, respectively. The database server and predictive algorithm system or model can apply one or more algorithms to this stored database to estimate parameters that are specific to the tumor under study or a group of tumors. In addition, the database server management software can apply one or more models or algorithms to estimate future parameters of the tumor under study or a group of tumors. Based on the results of the algorithm, the database server management software can create a report for the user that includes parameters estimation or prediction or both.

  In an example of an alternative embodiment of the system 10, the database server and predictive model consists of a dynamic website running server software that enables analysis and reporting as a multi-user system. In another example embodiment, the database server and predictive model or algorithm system may also include the ability to transfer algorithm output and reports to computer software for analysis and interpretation by the user. In one embodiment, the database server and predictive model allows for real-time communication and updates to sensor data; parameter notification (eg, tumor progression, etc.); or level of alerting or both In some cases, a function to be added is included.

  In an example of an alternative embodiment of the system 10, the database server control software stores all the actual measurements acquired so far in the database. When new data recording files are obtained, they are added to the database. The user may record other data such as, but not limited to, the results of other tests (PET scan, CT scan, etc.), subject information (height, weight, etc.), or other notes. Can be added. The user graphs the measured values using the database server control software, performs various calculations using the measured values, graphs them as needed, and uses prediction algorithms on the data. You can. Predictive models include, but are not limited to, (1) the therapeutic effect on the tumor, (2) which of the treatments on the tumor is most likely to be successful, (3) the subject has a metastatic disease Possibilities and / or (4) other predictions can be made. The database server control software can create reports such as predictions based on actual measurements and / or data to the user. Reports include, but are not limited to, graphs and prediction confidence limits.

  In any example embodiment of the system of the present invention, the type of algorithm used is based on the classification used in machine learning. These algorithms use a training data set to build a model of the data. This allows the algorithm to determine where in the model this new data corresponds when an unknown data set is introduced. With this approach, the system of the present invention can examine the acquired data set and determine if there have been cases in the past that may be equivalent or similar to the acquired data set. If there are similar cases in the past, the system can predict the results of the current data based on the results of the past data. For example, if there are some past cases that closely match newly acquired data, the algorithm can determine which treatment has been most effective so far. This allows the physician to select the most effective treatment. In another example embodiment, the algorithm is adapted to provide adaptive performance and measurement capabilities. For example, if tumor growth accelerates, the system can respond to that change and automatically increase the sample frequency.

  In an example embodiment of the system 10, the method of checking or determining whether newly acquired data matches past data is based on a plurality of mathematical or quantitative functions that can be applied to measurement data. For example, data set matches can be evaluated using methods such as area under the curve, polynomial curve fit for some or all data, ratio of data from paired measurement channels, and the like.

  Returning to the description of the figures, FIG. 27 shows details of an example embodiment representing an armband 78 having a fastener 79, such as a hook-and-loop fastener. An example of such an embodiment may combine a measurement sensor and a control device on the armband 78. FIG. 28 is an example of another embodiment in which the arm band 78 is combined with the measurement sensor 11 and the cable 24. FIG. 29 shows the details of the light shielding body 28 having the light shielding sealing material 81.

  FIG. 30 is a perspective exploded view of one side of an embodiment having a light shield 28 having or defining a light shield scintillation cavity 28A and a detector cavity 28B. Therefore, the scintillation crystal 20 and the photodetector 21 can be stored in these cavities and are protected by the light shielding seal material 81. FIG. 31 is another view of an example of the embodiment of the light shielding body 28, showing a light shielding sealing material 81 and an optional collimating position matching light source or LED 85. FIG. 32 is a cross-sectional view of FIG. 31 showing an example of an embodiment showing a relative positional relationship between the scintillation crystal 20 and the photodetector 21 in the light shield 28. FIG. 33 is a further exploded view of this embodiment, showing the interrelationship of the individual components having collimation alignment light source 85. FIG.

  FIG. 34 shows an example of an embodiment of the measurement control device 12 having a communication line 7, a plurality of control device communication ports 47 and an optional control device connection port 46. FIG. 35 shows two linked control devices.

  FIG. 36 shows an example of an embodiment of the measurement sensor housing 25 having the cable 24. FIG. 37 is an external view of an example of another embodiment of the measurement sensor housing 25 having the light shielding body 28 and the sensor circuit board 23. FIG. 38 is a partially exploded view of the embodiment of FIG. 37, showing the light detector 21 and scintillation material 20 for the light shield 28 and sensor housing 25. FIGS. 39 and 40 show the opposite side of an example embodiment having a radiation shield alignment device 87 and a collimation alignment device 85. FIG. 41 shows the radiation shield 84. 42 and 43 show details of the radiation shield 84. 44 is an outer bottom view of an embodiment of the measuring sensor 11 having a radiation shield 84, and FIG. 45 shows an exploded view of the same embodiment with individual parts.

  FIG. 46 is a cross-sectional view of an example embodiment of a measurement sensor 11 attached to a radiation shield 84 that defines a collimation, having a scintillation material 20 and a photodetector 21. FIG. 47 is a cross-sectional view of an example of another embodiment of measurement sensor 11 that optionally shows collimation position alignment device 85. FIG. 48 is a further cross-sectional view of an example embodiment having different configurations for collimation alignment device 85.

  FIG. 49 is a perspective view of an example of an embodiment of the measurement sensor 11 having the measurement sensor stand 83. FIG. 50 is an enlarged view of the embodiment of FIG. FIGS. 51 and 52 show two different perspective views of the details of an embodiment with an optional radiation shielding adjustment foot 97.

  FIG. 53 shows an example of some embodiments having two measuring sensors 11 connected by a cable 24. FIG. 54 is another embodiment in which the second measurement sensor 11 is connected to the first measurement sensor 11 having the shielding mask 84. FIG. 55 illustrates various form factors for a particular embodiment of a measurement sensor 11 having a particular application. FIG. 56 is an example of an optional sensor trigger push button embodiment.

  FIG. 57 is a cross-sectional view of the measurement sensor 11 with the backscattering material 8 emphasized. FIG. 58 shows in detail the structure of the sensor housing 25 for measurement that can be used as a base for the backscattering material 82.

  Some embodiments of the system 10 are directed to the real-time detection of gamma rays emitted by a subject outside the body, over time from administration to accumulation of a radiological specimen that decays by positron emission in the body. These systems 10 may include at least a single computer processor 42 (not necessarily the same as the computer / processing station 70) having at least a single in vitro measuring sensor 11, a non-transient memory 40 and a clock 48. The computer processor 42, the temperature corrector 50, and the computer program code that are linked to the measurement sensor 11 through mutual communication. The extracorporeal measurement sensor 11 includes a sensor casing 25, a scintillation material 20, a photodetector 21, a temperature sensor 36, a signal amplifier 33, a sensor power source 32 (any one of a wire, a battery, a solar battery, and the like). . The photodetector 21, the temperature sensor 36, the signal amplifier 33, and the sensor power supply 32 are generally linked by mutual communication. The scintillation material 20 and the photodetector 21 are adapted so that the scintillation material 20 can capture a gamma ray level from a radiation sample in the body for a certain period and emit a photon corresponding thereto, and is shielded in the sensor housing 25. It is arranged with. The photodetector 21 is arranged so as to capture the photons converted according to the frequency level of the gamma rays captured with time with respect to the scintillation material 20 and convert them into signal data. The signal amplifier 33 is adapted to amplify the signal data, and the measuring sensor 11 has at least a single sensor output for such amplified signal data.

  At least one computer processor 42 may include a non-transient memory 40 and a clock 48, which interacts with the measurement sensor 11 in intercommunication. The memory 40 has computer program code for control that can be executed by at least one computer processor 42. The computer program code for control includes a plurality of software modules such as a first module 61 for measurement and a second module 62 for data management.

  An optional temperature compensator 50 is paired with the temperature sensor to adapt the temperature sensor 36 to measure ambient temperature. As such, the system 10 may be adapted to communicate the ambient temperature to the temperature corrector 50, which may generate a temperature correction index based on a comparison of the ambient temperature to a reference temperature. Furthermore, the temperature corrector 50 is adapted to generate a temperature correction index in the signal data to generate temperature corrected signal data.

  The first module 61 is adapted to receive the signal data in the recording file format, and the second module 62 receives the signal data of the recording file from the first module 61 and transfers the corrected signal data to a predetermined recording device. Fit as you can. The computer program code 56 can further receive the stored data of the recording file from the second module 62 and apply such stored data to calculate the change in the corrected signal data for a predetermined period. An adapted third module 63 is included. The module also applies the stored data to the prediction model, generates a prediction data value for a predetermined period for such a recording file as a prediction result, and changes such changes to a predetermined recording such as the database recording device 75. Transfer to device.

  Optionally, the external measurement sensor 11 may include a radiation shielding mask 84 for gamma rays. The shielding mask 84 defines a collimator 84 c as an opening for gamma rays incident on the scintillation material 20. An alignment function 87 can be included to make the measurement sensor 11 detachable with respect to the subject 5. In some cases, the alignment function 87 may arrange the light emitter 85 that illuminates the subject 5 in the sensor 11 so that the collimating aperture 84c can be aligned with a predetermined position of the subject 5. Optionally, the light emitter 85 may be a light emitting diode (LED) disposed within the aperture, and optionally, the extracorporeal measurement sensor 11 may detect that the diode output or natural light strikes the scintillation material 20. It includes an LED 85 having a light-shielding sealing material 81 arranged around it so as to prevent incident gamma rays from hitting the scintillation material 20.

  Optionally, the extracorporeal measurement sensor 11 may further include a radiation shielding mask 84 for gamma rays that defines a collimator 84 c as an opening for gamma rays incident on the scintillation material 20. In addition, the system 10 further detachably mounts the external measurement sensor 11 on the subject 5 so that the opening of the collimator 84c can be aligned with a predetermined position of the subject 5. A possible alignment function 87 and a stand 83 are provided.

  Optionally, the third module 63 detects an extravasation condition. In one approach, the third module 63 calculates a corrected change in signal data so that extravasation of the radioactive specimen can be determined. In other approaches, the predictive model includes data representing the frequency of radiation over time associated with extravasation of a specimen in a subject to determine extravasation. The predictive model may include data representing spikes in the frequency of radiation over time associated with sample administration to determine proper administration of the sample. A warning or indicator may be included to inform the determination of extravasation. Further optionally, some embodiments include an armband 78 for detachably attaching the external measurement sensor 11 to the arm of the subject 5.

  Optionally, a noise reduction filter 37 is included to filter the amplified signal data based on the amplitude. The filter may be incorporated into a voltage comparator. Alternatively, the filter includes an analog to digital converter and control computer program code that can compare the digitally amplified signal data to a reference level.

  Further system 10 embodiments are also intended for real-time in vitro detection of gamma rays emitted in a region of interest by a subject from time-course from administration to accumulation of radioactive analytes attenuated by positron emission in the body. . Such an embodiment may include a first extracorporeal measurement sensor 11 and a second extracorporeal measurement sensor 11. The first external measurement sensor 11 may include a sensor housing 25 having a radiation shield 84, the sensor housing 25 having the radiation shield 84 defines a cavity, and the radiation shield 84 further includes The aperture is defined in the cavity as a collimator 84c disposed in the aperture to receive the gamma rays collimated in the cavity from the region of interest, and the scintillation material 20 Arranged in the cavity so as to be incident, the photodetector 21 is arranged in a sensor casing 25 for guiding the light emitted from the scintillation material 20, and includes a temperature sensor 36, a signal amplifier 33, and a sensor power source. 32. The photodetector 21, the temperature sensor 36, the signal amplifier 33, and the sensor power supply 32 are linked by mutual communication.

  In general, the scintillation material 20 and the photodetector 21 receive a gamma ray at a predetermined period and level from a radioactive specimen in the body in the sensor casing 25 and can emit photons corresponding to the gamma ray level. 20 together. As described above, the photodetector 21 is adapted to receive the multiplied photons and convert them to signal data corresponding to the frequency level of the received gamma rays over time, and is disposed relative to the scintillation material 20. . The signal amplifier 33 amplifies the signal, and the measurement sensor 11 has at least one sensor output (for example, the port 27) for the amplified signal data.

  In this embodiment, collimation alignment that works with the sensor housing 25 to align the second external measurement sensor 11 and the collimator 84c that are not shielded to measure background gamma rays with the region of interest. A system 87 is included.

  The temperature compensator 50 is paired with the temperature sensor in order to adapt the temperature sensor 36 to measure the ambient temperature. As such, the system 10 is adapted to communicate the ambient temperature to the temperature corrector 50, which calculates the temperature correction index based on a comparison of the ambient temperature to the reference temperature. The temperature corrector 50 is further adapted to apply a temperature correction index to the signal data to calculate the temperature corrected signal data.

  At least one computer processor 42 includes a non-transient memory 40 and a clock 48, and the computer processor 42 interacts with the first and second measurement sensors 11 in mutual communication. The memory 40 has or stores a control computer program code 56 executable by at least one computer processor 42, the control computer program code 56 being a first module 61 for measurement and a second module for data management. A module 62 is included. The first module 61 is adapted to receive signal data in a recording file format. The second module 62 is adapted to receive the signal data of the recording file from the first module 61 and transfer the corrected signal data to a predetermined recording device (for example, the database recording device 75). Or includes a third module 63 and a fourth module 64 of computer program code 56, wherein the third module 63 is adapted to receive the stored data of the recording file from the second module, and (i) such stored Applying the data to the prediction model to generate prediction data for a predetermined period for such a recording file as a prediction result, transferring such prediction result to a predetermined recording device, and (ii) such stored data Is applied to calculate a change in the corrected signal data for a predetermined period and is adapted to transfer such a change to a predetermined recording device, and the fourth module 64 is supplied from the second external measurement sensor 11. The signal data is adapted to be subtracted from the signal data from the first external measuring sensor 11 having the radiation shield 84.

  This embodiment includes various options corresponding to the options of the above-described embodiments regarding the shielded first extracorporeal measurement sensor 11 as necessary. The second measuring sensor 11 remains unshielded for detection of background radiation.

  Some embodiments are specifically aimed at identifying the appropriateness of a radioactive specimen for a subject, or improper administration, for example, not limited to extravasation. An example of such an embodiment is a system 10 for real-time detection outside the body for a certain period of time of gamma rays emitted by the subject 5 from administration of radioactive specimens that decay in the body. The parameter pattern (ie, amplitude, slope and / or time) of the data from either proper or incorrect administration or both is used as reference data. The system can determine the likelihood of proper (or improper) administration of a radioactive sample to a subject by comparing the amplified signal data from the administration with a parameter model and comparing it with reference data. it can.

  In this case, the system 10 includes at least one external gamma ray measuring sensor 11 for detecting gamma rays for a predetermined period and generating signal data for the period. The extracorporeal measurement sensor 11 can detect gamma rays in the vicinity of the site where the radiation sample is administered to the subject 5 of the radioactive sample. The signal amplifier 33 is linked to the gamma ray sensor 11 by mutual communication in order to amplify signal data. As described above, the measurement sensor 11 includes at least a single sensor output or port for communicating such amplified signal data. The data is processed by at least one computer processor 42 that is interrelated or associated with the non-transient memory 40. The computer processor 42 can also interact with the measuring sensor 11 at the output terminal.

  The non-transient memory 40 compares a procedure for receiving amplified signal data in a predetermined period, a procedure for accessing reference data distributed in the reference period, and the amplified signal data with reference data using a model of parameters. It has computer program code 56 executable by the computer or control processor 42 to execute a procedure for determining the possibility of proper administration of the radioactive specimen to the subject 5. The computer program code 56 may further normalize the amplified signal data, and the parameter model may be one or more time dependent functions of the amplitude and slope of the amplified signal data.

  Embodiments range from administration of radioactive specimens that decay in the body to technique 100 for real-time detection of a period of gamma radiation emitted by the subject, as shown in FIG. Such a method includes (i) the application of at least a single external gamma ray measuring sensor 11 and method 100 close to the administration site in the subject 5 of the radioactive specimen, and (ii) detecting 120 gamma rays for a predetermined period. Generate signal data for this period, (iii) amplify the signal data 130 using a signal amplifier that interacts with the gamma ray sensor, and the measuring sensor is at least for such amplified signal data. A single sensor output, output amplified signal data, and (iv) perform a procedure such as processing 140 using a computer processor that interacts the amplified signal data with the non-transient memory and the sensor output for measurement. Including the following procedure: (a) receiving signal data amplified in a predetermined period 142; (b) non-transient memory from a reference period distributed in a reference period Access to data 144, (c) By comparing the amplified signal data with reference data using a model of parameters, whether the radioactive sample was properly administered in the body of the subject The determination 146 and the like are included. Optionally, the processing 140 of the amplified signal data may further include a procedure for normalizing the amplified signal data. The parameter model is also a first-order or higher-order time series function of the amplitude and slope of the amplified signal data.

  An embodiment of the system 10 includes an external measurement sensor 11 having a sensor housing 25, a scintillation material 20 as a gamma ray detector or sensor, a photodetector 21, a signal amplifier 33, and a sensor power supply 32. Not as long. The photodetector 21, the signal amplifier 33, and the sensor power supply 32 are linked by mutual communication. The scintillation material 20 and the photodetector 21 receive a certain period and level of gamma rays from the radioactive specimen in the body, and together with the scintillation material 20 capable of emitting photons corresponding to the level of the gamma rays, the sensor housing is shielded from light. Located in the body 25. The photodetector 21 is arranged with respect to the scintillation material 20 in order to convert it into signal data corresponding to the frequency level with time of the received gamma rays hitting the photon. The signal amplifier 33 amplifies the signal data, and the measuring sensor 11 has at least a single sensor output 27 for such amplified signal data. At least one computer processor 42 is associated with the non-transient memory 40 and the clock 48, and the computer processor 42 is in communication with the non-transient memory 40 and the measuring sensor 11. The non-transient memory 40 receives the amplified signal data in a recording file format, transfers the amplified signal data to a predetermined recording device, accesses reference data from the predetermined recording device, and stores such amplified signal data. Maintains computer program code 56 for control that can be executed by the computer processor 42 to apply the model of parameters to compare the signal data with reference data and determine the likelihood of proper administration of the radioactive sample to the subject Or include. As described above, the amplified signal data is standardized, and the parameter model is a first-order or higher-order time series function of the amplitude and gradient of the amplified signal data.

  Any of the amplified signal data resulting from both proper and improper administration of the radioactive analyte, along with the methods and steps used for injection, will include variations on the total radioactivity of the radioactive analyte. For example, the injection spike signal varies in amplitude depending on the entire injection process, or the rate of increase of the amplified signal data varies depending on the rate at which the radioactive analyte is injected.

  One approach to account for variations caused by the above is to normalize the amplified signal data based on the maximum value of the recorded amplified signal. By scaling the amplified signal data so that the scaled maximum is, for example, 1, the amplified signal data in various cases can be compared with each other even when the injection process is quite different. An example of another approach to normalize amplified signal data is to scale the amplified signal data based on the total measurement of the injected radioactive analyte instead of the foregoing.

  A parameter model for the analysis or parameter model performed on the amplified signal data in order to be able to determine the likelihood or probability that the administration of the radioactive sample is appropriate (eg, accurate and conforms to clinical procedures) Includes various algorithms that compare the amplified signal data with reference data so that similarities or differences can be calculated. As described above, the parameter model is a first-order or higher-order time series function of the amplitude and gradient of the amplified signal data.

  With respect to the model of parameters, a data set of one or more amplified signal data can be used as a criterion to indicate that the administration of the radioactive analyte was appropriate, while one or more other amplified signals The data set of data can be used as a basis for indicating that the administration of the radioactive specimen was inappropriate. As an example of embodiment, for example, for a specific portion of the amplified signal data, the number of seconds during which the amplified signal data is higher than a specific threshold is added. For example, in FIG. 24, when the threshold is set to 500, 0 to 10 are counted. A specific period in which the amplified signal data is higher than the threshold can be compared by applying the same algorithm to the reference data. And due to the relative similarity or difference in the counts calculated to exceed the threshold, the amplified signal data will indicate the likelihood or probability that the administration of the radioactive specimen has been properly performed on the subject. Show.

  Similarly, in an example of another embodiment of the parameter model, instead of calculating the count when the amplified signal data exceeds the threshold, the integral of the amplified signal data for the period exceeding the threshold is calculated. Then, by applying the same algorithm to the reference data, similarly, the amplified signal data indicates the possibility of proper administration of the radioactive specimen.

  In addition, a parametric model including a polynomial statistically approximates the amplified signal data samples so that the best approximation can be provided. Homogeneous polynomials are similarly approximated to the reference data set. Then, by comparing the coefficients of the polynomial, the amplified signal data indicates the possibility of whether the administration of the radioactive specimen is appropriate.

  It is also used as a model of parameters for comparing the amplified signal data with the reference data dataset by an artificial intelligence neural network or cluster analysis algorithm. These algorithms compare the amplified signal data with reference data known as proper dosing and known data representing improper dosing. The algorithm then indicates the possibility that the amplified signal data belongs to which group.

  A computer system having reasonable program means or modules to operate in accordance with the disclosed method is easily within the scope of the present invention for those skilled in the art. A computer system specially configured to have reasonable program means that can satisfy the above-described objects can be realized. Valid program means include all methods that direct a computer system to perform the steps of the method and system of the present invention, for example, computer memory is a processing unit and arithmetic logic circuit pair, and the system is computer memory. The computer memory may include an electrical circuit configured to store data, and the method of the present invention that can be performed by the processing unit can also be programmed with each programmed instruction. All aspects of the invention can also be included in a computer program product that includes a non-transient recording medium or the like that works with a valid data processing system. The current system can operate on a wide variety of platforms, including a wide variety of basic software. Appropriate hardware, software, and programming are included that can execute instructions from the computer among the different elements and components of the present invention.

  The present invention may be embodied in other forms without departing from its spirit or essential characteristics. Therefore, the present embodiment is illustrative in all respects, but is not limited thereto, and the scope of the present invention is not the above-described content but the claimed content of the application, and therefore has the same meaning as the claimed content and All changes in scope are intended to be included herein.

DESCRIPTION OF SYMBOLS 1 Tumor 2 Upper right arm 3 Left upper arm 4 Liver 5 Subject 7 Communication line 10 System 11 Measurement sensor 12 Control device 14 Server control software 16 Measurement sensor identification function 20 Scintillation material 21 Photodetector 21A Active area 22 Sensor processor 23 Board 23A First surface 23B Second surface 23P Printed circuit board assembly 24 Multi-conductor cable 25 Sensor housing 25F Anchor 25L Length of sensor housing 25S External surface of sensor housing 27 Sensor output port 28 Light shield 28A 1st cavity 28B 2nd cavity 21 Photo detector 30 Memory for non-transient sensor 31 Light emitting part 32 Power supply for sensor 33 Signal amplifier 35 Sensor carrier for measurement 35A Adhesive 35F Alignment function 36 Temperature sensor 37 Noise reduction filter 38 Shielding mask 40 non Transient control memory 42 Control processor 46 Daisy chain connection port 47 Control input port 48 Clock 50 Temperature corrector 52 Control power supply 56 Control computer program code 61 1st module 62 2nd module 63 3rd module 64 4th module 70 Processing station 71 Docking device 75 Database 76 Station computer program code 77 Internet 78 Arm band 79 Fastener 80 Record file 81 Light shielding seal material 82 Back scattering material 83 Sensor sensor and 84 for measurement Shielding mask 84c Collimation aperture 85 Collimation alignment device 87 Alignment function 88 Low level portion prior to injection 89 Injection spike 90 Low level portion after injection 92 Low level portion of non-administered arm 95 Non-administered arm The method of the low level portion 100 outside real-time detection

Claims (36)

A system for the real-time detection of gamma rays emitted outside the body by a subject up to a certain period of time during the administration and accumulation of radioactive specimens attenuated in the body by positron emission,
The system includes at least one external measurement sensor having a sensor housing, a scintillation material, a light detector, a temperature sensor, a signal amplifier, and a sensor power supply;
The photodetector, the temperature sensor, the signal amplifier and the sensor power supply are linked by mutual communication,
The scintillation material and the photodetector are installed in the sensor housing in a light-shielded state, and the scintillation material receives a gamma ray level for a predetermined period from a radioactive specimen in the body, and generates photons corresponding to the gamma ray level. Adapted to emit and the photodetector is installed on the scintillation material to receive the photons and convert the photons into signal data corresponding to the frequency level of the received gamma rays over time. ,
The signal amplifier is adapted to amplify the signal data, and the measuring sensor has at least one sensor output for the amplified signal data;
At least one computer processor has a non-transient memory and a clock, and the computer processor interacts with the measurement sensor by intercommunication,
The memory includes control computer program code executable by at least one computer processor, the control computer program code including a first module for measurement and a second module for data management;
The first module is adapted to receive the signal data in a recording file format;
The system further includes a temperature compensator paired with the temperature sensor, the temperature sensor being adapted to measure an ambient temperature, the system being able to communicate the ambient temperature to the temperature corrector; A temperature corrector is adapted to generate a temperature correction index based on a comparison of the ambient temperature with a reference temperature, and the temperature corrector is further temperature corrected by applying the temperature correction index to the signal data. Adapted to generate
The second module is adapted to receive the signal data of the recording file from the first module and transfer the corrected signal data to a predetermined recording device;
The computer program code further receives stored data of a recording file from the second module, calculates the change in the corrected signal data for a predetermined period by applying the recorded data, and stores the stored data Including a third module capable of generating a prediction data value of a predetermined period related to the recording file as a prediction result by applying to a prediction model, and transferring the change to a predetermined recording device.   The external measurement sensor according to claim 1, further comprising a radiation shielding mask for gamma rays.   The in vitro measurement sensor according to claim 2, wherein the shielding mask defines an aperture as a collimator for gamma rays incident on the scintillation material.   The extracorporeal measurement sensor according to claim 2, further comprising a matching function for detachable positioning of the measurement sensor with respect to the subject.   The alignment function includes a light emitting unit disposed in the sensor so that the alignment of the aperture of the collimator can be performed at a predetermined position of the subject by irradiating the subject. Item 5. The external measurement sensor according to Item 4.   The light emitting unit is a light emitting diode disposed in the aperture, and the external measurement sensor further prevents the output of the diode or natural light from directly irradiating the scintillation material, while the scintillation material is incident. 6. The external measurement sensor according to claim 5, further comprising a light-shielding sealing material around the light emitting diode, which enables reception of gamma rays.   The external measurement sensor further includes a radiation shielding mask for gamma rays, the shielding mask defines a collimator aperture for gamma rays incident on the scintillation material, and the system further comprises the subject. A stand alignment function for detachably mounting the external measurement sensor in a configuration relative to the subject so that the aperture of the collimator can be aligned with a predetermined portion of the collimator The system of claim 1, comprising:   The system of claim 1, further comprising a filter that filters the amplified signal data based on amplitude.   The system of claim 8, wherein the filter includes a voltage comparator.   9. The system of claim 8, wherein the filter further comprises an analog to digital converter capable of comparing digitally amplified signal data to a reference level and control computer program code. A device for detecting radiation,
Including a measurement sensor having a housing, a scintillation material, a photodetector, a light shield, a temperature sensor, a signal amplifier, a sensor processor, a memory for a non-transient sensor, and a power supply for the sensor,
The photodetector, the signal amplifier, the sensor processor, the sensor memory, and the sensor power supply are interlocked with each other by a printed circuit board assembly, and the printed circuit board assembly includes a first surface and an opposite first surface. Defining a plane having two surfaces, wherein the light shield can be placed on the first surface of the substrate, shielding the scintillation material and the photodetector from natural light;
The scintillation material has a first width parallel to the plane; the photodetector has a second width parallel to the plane;
The light shield defines a first cavity having a third width greater than or equal to the first width, the first cavity being adapted to receive the scintillation material; Defining a second cavity having a fourth width greater than or equal to two, wherein the second cavity can receive the photodetector;
The scintillation material and the photodetector are disposed within a light shield, the scintillation material can receive a level of gamma rays and emit photons corresponding to the level of the gamma rays, and the photodetector can increase. Arranged with respect to the scintillation material so that the multiplied photons can be received and converted into signal data corresponding to the received radiation level;
When the scintillation material is received by the first cavity and the photodetector is received by the second cavity, the light shield optically aligns the scintillation material with the photodetector; and The first and second cavities are in communication and in close proximity so as to communicate with the printed circuit board assembly through mutual communication;
The signal amplifier is adapted to amplify the signal data, the sensor memory includes a sensor identification function for measurement, and the measurement sensor has at least one sensor output port for the amplified signal data; machine. The light-shielding body is mounted on the first surface of the substrate with solder;
12. The apparatus of claim 11, wherein the light shield is selected from the group consisting of copper, brass, bronze, steel, aluminum, white, beryllium copper, silver, gold and nickel metals. A system for in vitro real-time detection of gamma rays emitted in a region of interest by a subject from administration and absorption over a period of time of a radioactive analyte that decays in the body by positron emission,
The system includes a first external measurement sensor having a sensor housing with radiation shielding, wherein the sensor housing having the radiation shielding defines a cavity, and the radiation shielding is further within the cavity. An aperture is defined, a collimation is placed in the aperture such that a gamma ray collimated from a region of interest into the cavity enters the scintillation material in the cavity so that the collimated gamma ray is incident on the scintillation material Disposed in the sensor casing so as to detect light emitted from the scintillation material, and the first external measurement sensor further includes a temperature sensor, a signal amplifier, and a sensor. Power supply for
The photodetector, the temperature sensor, the signal amplifier, and the sensor power supply are linked to each other,
The scintillation material and the photodetector are disposed in the sensor housing, and the scintillation material receives a certain level of gamma rays from a radioactive sample in the body over a predetermined period of time and emits photons representing the level of the gamma rays. The photodetector is arranged relative to the scintillation material to receive the multiplied photons and convert them into signal data representing a frequency level of received gamma rays over time;
The signal amplifier can amplify the signal data, and the measuring sensor has at least a single sensor output for the amplified signal data;
The system further includes a second extracorporeal measuring sensor that is not shielded to measure background gamma rays;
A collimation alignment system that works in conjunction with the sensor housing to align the collimation with the region of interest;
A minimum of a single computer processor having a non-transient memory and a clock and interlocking with the first and second measurement sensors.
The memory includes control computer program code executable by at least one computer processor, the control computer program code including a first module for measurement and a second module for data management;
The first module can receive the signal data in a recording file format;
The system further includes a temperature corrector paired with the temperature sensor, the temperature sensor can measure an ambient temperature, the system can communicate the ambient temperature to the temperature corrector, and the temperature A corrector generates a temperature correction index based on a comparison of the ambient temperature with a reference temperature, and the temperature corrector further applies the temperature correction index to the signal data to generate temperature-corrected signal data. Can
The second module can receive the signal data of the recording file from the first module and transfer the corrected signal data to a desired recording device;
The computer program code further includes third and fourth modules, wherein the third module receives stored data of the recording file from the second module, and (i) applies the stored data to the prediction model Then, a predicted data value over a desired period related to the recording file is generated as a predicted result, the predicted result is transferred to a desired recording device, and (ii) the stored data is applied to a desired period. The change of the corrected signal data can be calculated and the change can be transferred to a desired recording device, and the fourth module receives the signal data from the second external measurement sensor as the first external expression. A system that can be subtracted from signal data from a measuring sensor.   The system of claim 13, wherein the first external measurement sensor further comprises a radiation shielding mask for gamma rays.   15. The system of claim 14, wherein the first extracorporeal measurement sensor shielding mask defines an aperture in the form of a collimation with respect to gamma rays incident on the scintillation material.   The system according to claim 14, wherein the first external measurement sensor further includes an alignment function for removably aligning the first external measurement sensor with respect to the subject.   The first extracorporeal measurement sensor alignment function is arranged in the sensor so that the collimation aperture can be aligned with a desired portion of the subject by irradiating the subject. The system according to claim 16, comprising a light emitting part.   The light emitting part of the first external measurement sensor is a light emitting diode disposed in the aperture, and the external measurement sensor further detects that the output from the diode or natural light collides with the scintillation material. 18. The system of claim 17, comprising a light shielding seal around the light emitting diodes to prevent, while allowing the scintillation material to receive incident gamma rays.   The first extracorporeal measurement sensor further includes a radiation shielding mask for gamma rays, the shielding mask defines a collimator aperture for gamma rays incident on the scintillation material, and the system further comprises: 14. A stand alignment function for detachably mounting the external measurement sensor in a configuration relative to the subject so that the aperture of the collimator can be aligned with a predetermined portion. The system described in.   The system of claim 16, further comprising a filter for filtering the amplified signal data based on amplitude.   21. The system of claim 20, wherein the filter includes a voltage comparator.   21. The system of claim 20, wherein the filter further comprises an analog to digital converter capable of comparing the digitally amplified signal to a reference level and control computer program code. A system for real-time detection during a period of gamma rays emitted from the administration of a radioactive specimen that decays in the body to the outside of the body,
At least a single external gamma ray measurement sensor capable of detecting gamma rays for a predetermined period, generating signal data relating to the predetermined period, and detecting gamma rays near the administration site of the subject of the radioactive specimen When,
A signal amplifier that is linked to the gamma ray sensor through mutual communication, wherein the signal amplifier can amplify the signal data, and the measurement sensor outputs at least one sensor output for the amplified signal data. A signal amplifier;
A computer processor and a non-transient memory, at least a computer processor and a non-transient memory, wherein the computer processor is in communication with the non-transient memory and the measurement sensor output port;
The non-transient memory includes computer program code executable by at least one computer processor, wherein the computer program code receives the amplified signal data in the predetermined period and is distributed in a reference period Performing a procedure to access data and compare the amplified signal data with the reference data using a model of parameters to determine the likelihood of proper administration of the radioactive specimen to the subject Configured system.   24. The computer program code may further normalize the amplified signal data, and the model of the parameter is a time series function of one or more amplitudes and slopes of the amplified signal data. The system described in.   25. The system of claim 24, wherein the normalization is for a maximum value of the amplified signal data during the period.   25. The system of claim 24, wherein the parameter model includes an integration of the amplified signal data for at least one period of the period.   25. The system of claim 24, wherein the model of parameter comprises comparing the amplified signal data to a specific threshold of the reference data corresponding to extravasation of the radioactive specimen. The at least one sensor for measuring an external gamma ray includes a sensor casing, a scintillation material, a photodetector, a signal amplifier, and a sensor power supply.
The photodetector, the signal amplifier and the sensor power supply are linked by mutual communication,
With the scintillation material capable of receiving a certain level of gamma rays from a radioactive specimen in the body in a state where the scintillation material and the photodetector are shielded from light and emitting photons corresponding to the level of the gamma rays, Disposed within the sensor housing, the photodetector is disposed relative to the scintillation material to receive the photons and convert the received photons into signal data corresponding to a frequency level over time of the received gamma rays. 24. The system of claim 23.   29. The computer program code can further normalize the amplified signal data, and the model of the parameter is one or more time series functions of the amplitude and slope of the amplified signal data. The system described.   30. The system according to claim 29, further comprising an arm band for removably fixing the external measurement sensor to the subject's arm.   30. The system of claim 29, further comprising an alarm to signal an inappropriate dosing decision. A method for the real-time detection of gamma rays released from the body by administration of radioactive specimens that decay in the body over time,
(I) disposing at least a single external gamma ray measurement sensor in the vicinity of the site of administration of the radioactive specimen to the subject;
(Ii) detecting gamma rays for a predetermined period and generating signal data relating to the predetermined period;
(Iii) amplifying the signal data using a signal amplifier that is in communication with the gamma ray sensor, and the measuring sensor has at least a single sensor output for such amplified signal data; Outputting the amplified signal data;
(Iv) processing the amplified signal data using a non-transient memory and a computer processor that interacts with the measurement sensor output by mutual communication,
(A) receiving the amplified signal data for the predetermined period;
(B) accessing reference data distributed during a reference period from the non-transient memory;
(C) Using a parameter model, comparing the amplified signal data with the reference data to determine whether the administration of the radioactive sample has properly administered the radioactive sample to the subject Performing a process by performing a process, and
Including the method.   The processing of the amplified signal data further includes normalizing the amplified signal data, and the model of the parameter is one or more time series functions of the amplitude and gradient of the amplified signal data. 35. The method of claim 32.   34. The method of claim 33, wherein the normalization is for a maximum value of the amplified signal data for the period.   34. The method of claim 33, wherein the parameter model comprises an integration of the amplified signal data for at least one period of the period.   34. The method of claim 33, wherein the model of parameter comprises comparing the amplified signal data to a specific threshold of the reference data corresponding to extravasation of the radioactive specimen.