WO2012076958A2 - Procédé de criblage - Google Patents

Procédé de criblage Download PDF

Info

Publication number
WO2012076958A2
WO2012076958A2 PCT/IB2011/002937 IB2011002937W WO2012076958A2 WO 2012076958 A2 WO2012076958 A2 WO 2012076958A2 IB 2011002937 W IB2011002937 W IB 2011002937W WO 2012076958 A2 WO2012076958 A2 WO 2012076958A2
Authority
WO
WIPO (PCT)
Prior art keywords
psa
prostate
pathway
screening
anode
Prior art date
Application number
PCT/IB2011/002937
Other languages
English (en)
Other versions
WO2012076958A3 (fr
Inventor
Albert Maarek
Original Assignee
Albert Maarek
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Albert Maarek filed Critical Albert Maarek
Priority to BR112013013619A priority Critical patent/BR112013013619A2/pt
Publication of WO2012076958A2 publication Critical patent/WO2012076958A2/fr
Publication of WO2012076958A3 publication Critical patent/WO2012076958A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4375—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the male reproductive system
    • A61B5/4381—Prostate evaluation or disorder diagnosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6829—Foot or ankle

Definitions

  • the present invention relate to the use of bioimpedance measurement in a rapid, cost- effective, and noninvasive adjunct to digital rectal examination and PSA in differentiating tumor from normal prostatic tissue.
  • prostate cancer is the most commonly diagnosed malignancy and the second leading cause of mortality from cancer in men.(l) In 1997, there were at least 209,900 new cases of prostate cancer diagnosed and more than 41,800 deaths from prostate cancer.(2) At present, a transrectal ultrasound with prostatic biopsy is recommended in men with an abnormal digital rectal examination and/or an elevated prostate-specific antigen (PSA) level, and who are potential candidates for therapy.
  • PSA prostate-specific antigen
  • Bioimpedance is an electrical property of living tissue that has been shown to be a safe technique when used in a number of biomedical applications, including for quantification of brain edema in neurosurgery (7) and for differentiating between cancer and pneumonia on discovery of a pulmonary mass.
  • Electric current is normally limited in living tissue by highly insulating cell membranes. However, the abnormal architecture in cancerous tissue may impede current differently and allow detection of differences between normal and abnormal or malignant prostate tissue. (9)
  • the present inventor has devised a novel and inventive method and apparatus to assess the utility of bio impedance measurement as a rapid, cost-effective, and noninvasive adjunct to digital rectal examination and PSA in differentiating tumor from normal prostatic tissue.
  • a bio impedance based method for use in differentiating between tumor and normal prostatic tissue wherein the method measures resistance or conductivity in a pathway that passes through the prostate.
  • the pathway passes from one foot to the other.
  • the method of the invention preferably measures the delta of the electrical resistance values between the pathway value left foot- right foot (anode to cathode) minus the pathway value right foot-left foot (cathode to anode)
  • the invention also provides apparatus to measure bioimpedance in the prostate region for use in differentiating between tumor and normal prostatic tissue.
  • the apparatus is an EIS based system as described herein.
  • the invention also relates to the use of the EIS system in a screening method to differentiate between tumor and normal prostatic tissue.
  • the invention also relates to the use of the apparatus and method as described herein the adjunct to PSA and/or other screening methods for prostate cancer.
  • Figure 1 shows a Roc curve for PSA value greater than 4 and tissue diagnosis
  • Figure 2 shows a Roc curve for the PSA value greater than 5.7 and tissue diagnosis
  • Figure 3 shows a Roc curve for EIS pathway data and tissue diagnosis
  • Figure 4 shows a Roc curve for PSA-EIS data and tissue diagnosis.
  • the second explanation could be the electrochemical reaction in the anode related to the Chloride ions migration.
  • the electrochemical reaction provides 4 H+ and is therefore an acid environment.
  • Inclusion criteria were a high PSA test result (>4 ng/mL) and/or a positive digital rectal examination with a clinical recommendation of prostate biopsy. Patients were excluded if they had previously undergone prostate-related chemotherapy or surgery, were currently receiving treatment for a prostatic disorder, had a neurological disorder precluding the ability to sign a consent form, if in the opinion of the investigator they were clinically unsuitable candidates for the trial, and/or had any contraindications to use of the EIS system.
  • EIS system Use of the EIS system is contraindicated in the presence of an external defibrillator, skin lesions likely to come into contact with the electrodes, excessive perspiration, sinusitis (particularly frontal), cardiac pacemaker, electronic life support, any implanted electronic device, inability to remain still for three minutes, metallic pins or prostheses in digits or joints, pregnancy from the third trimester onwards, and absence of a limb.
  • the parameter used by the EIS is the delta of the electrical resistance values between the pathway value left foot- right foot (anode to cathode) minus the pathway value right foot-left foot (cathode to anode) expressed in numeric value
  • the EIS is a programmable electromedical system comprising a USB plug and hardware including an interface box, disposable electrodes, reusable plates, and reusable cables, with software installed on a computer.
  • the system uses bioimpedance in bipolar mode with direct current, and measures the electrical conductivity or resistance and the electrical dispersion of 1 1 pathways of the body, each recorded twice from anode to cathode and then from cathode to anode. The pathways are measured between four large tactile reusable electrodes (>270 cm ) placed on the palms of the hands and soles of the feet, and smaller disposable electrodes (15 cm 2 ) placed on the left and right forehead. Electrode polarization does not affect the bioimpedance measurement,(l 1) and the transmission of the current from the electrode to the hardware is performed by chronoamperometry.( 12)
  • the electrochemical reaction at the cathode is:
  • the electrochemical reaction for water at the anode is:
  • the output signal waveform is sent to the active electrode (anode or cathode) .
  • the signal waveform is rectangular, is continuous during 1 second / per human body pathway located between 2 electrodes. Each electrode is alternatively anode then cathode for each pathway This operation is realized 22 times (11 pathways) according to a programmed sequence.
  • the software receives 32 measurements of current during one second, converts the intensity and voltage in conductivity or resistance according to the Ohm law and then generates a graph for each pathway
  • the EIS parameter compared to PSA and biopsy results is the delta of the electrical resistance values between the pathway value left foot- right foot (anode to cathode) minus the pathway value right foot-left foot (cathode to anode)
  • the disease must constitute a serious public health problem
  • the disease must be able to be diagnosed during an asymptomatic, localized phase
  • the screening test must have an appropriate sensitivity, specificity, and predictive value
  • PSA values for prostate cancer and benign prostate hyperplasia overlap considerably. Between 21% and 47% of men with histologically proven benign prostate hyperplasia have PSA levels >4 ng/mL, and up to 43% of men with prostate cancer will have a PSA level ⁇ 4 ng/mL. This overlap makes it harder to differentiate benign prostate hyperplasia from prostate carcinoma in the absence of a biopsy. PSA values also increase with age.17
  • prostate cancer With prostate cancer, the risk of overdiagnosis is likely to be much more relevant than with other types of cancer screening, because in men aged 55-60 years, the risk of death from other causes is considerably higher than that from prostate cancer. It is estimated that for every patient who dies of prostate cancer, at least 380 others have prostate cancer that cannot be detected clinically.18
  • the treatment of prostate cancer consists of radical surgery or radiotherapy, and both can cause complications, including a high frequency of sexual impotence, rectal and urinary dysfunction, as well and a mortality risk of l%-2%.
  • the EIS technique when used as a screening test, meets the requirements of the World Health Organization guidelines stating that a screening test should be acceptable to the population, be rapidly performed (no more than two minutes), cost-effective and noninvasive, and that the total cost of finding a case should be economically balanced in relation to medical expenditure as a whole.
  • a small, organ-confined prostate tumor has an estimated doubling time of about four years. Thus, it will take about 15 years for a 1 mL tumor to become life-threatening. It would be more straightforward to say that until there is evidence for effectiveness of screening in decreasing mortality, based on these growth rates, a man would need to have at least 15 years of remaining life expectancy to benefit from PSA screening.
  • the EIS delta parameter had a good specificity of 85.2% and a sensitivity of 65.2%, although we noted that for the eight positive patients, none of which were identified by the delta parameter, four are undergoing diuretic treatment and one is receiving an alpha-blocker treatment.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analyzing Materials By The Use Of Electric Means (AREA)

Abstract

La présente invention concerne l'utilisation d'une mesure de bioimpédance dans un complément rapide, économique et non invasif à un examen rectal digital et à l'adsorption modulée en pression pour la différenciation d'une tumeur d'un tissu prostatique normal. Le procédé et l'appareil différencient une tumeur d'un tissu prostatique normal et mesurent la bioimpédance en termes de résistance ou de conductivité dans une voie qui passe à travers la prostate. De préférence, le procédé et l'appareil mesurent le delta des valeurs de résistance électrique entre la valeur de voie pied gauche-pied droit (anode vers cathode) moins la valeur de voie pied droit-pied gauche (cathode vers anode).
PCT/IB2011/002937 2010-12-06 2011-12-06 Procédé de criblage WO2012076958A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
BR112013013619A BR112013013619A2 (pt) 2010-12-06 2011-12-06 método para uso na diferenciação entre tumor e tecido prostático normal, aparelho para medir bioimpedância na região da próstata e uso de aparelho

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US45911410P 2010-12-06 2010-12-06
US61/459,114 2010-12-06

Publications (2)

Publication Number Publication Date
WO2012076958A2 true WO2012076958A2 (fr) 2012-06-14
WO2012076958A3 WO2012076958A3 (fr) 2012-08-02

Family

ID=45930913

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2011/002937 WO2012076958A2 (fr) 2010-12-06 2011-12-06 Procédé de criblage

Country Status (2)

Country Link
BR (1) BR112013013619A2 (fr)
WO (1) WO2012076958A2 (fr)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001076475A2 (fr) * 2000-04-07 2001-10-18 The Johns Hopkins University Detecteur de tumeur de la prostate chez l'homme
US8262575B2 (en) * 2002-05-20 2012-09-11 Epi-Sci, Llc Method and system for detecting electrophysiological changes in pre-cancerous and cancerous tissue
WO2006012181A1 (fr) * 2004-06-24 2006-02-02 Ksn Energies, Llc Tomographie a impedance electrique pour la caracterisation tissulaire

Non-Patent Citations (21)

* Cited by examiner, † Cited by third party
Title
ALAN W; PARTIN MD; MICHAEL W ET AL.: "Combination of Prostate-Specific Antigen, Clinical Stage, and Gleason Score to Predict Pathological Stage of Localized Prostate Cancer", JAMA, vol. 277, no. 18, 14 May 1997 (1997-05-14), pages 1445 - 1451
ARCANGELI CG; ORNSTEIN DK; KEETCH DW; ANDRIOLE GL.: "Prostate specific antigen as a screening test for prostate cancer. The United States experience", UROL CLIN NORTH AM., vol. 24, 1997, pages 299 - 306
CATALONA WJ; RICHIE JP; AHMANN FR ET AL.: "Comparison of digital rectal examination and serum prostate specific antigen in the early detection of prostate cancer: Results of a multicenter clinical trial of 6,630 men", J UROL., vol. 151, 1994, pages 1283 - 1290
CATALONA WJ; SMITH DS: "RatliffTL. Measurement of prostate specific antigen in serum as a screening test for prostate cancer", N ENGL J MED, vol. 324, 1991, pages 1156 - 1161
COCHRAN WG.: "Sampling Techniques", 1977, JOHN WILEY & SONS
COLE KS; LI CL; BAK AF.: "Electrical analogues for tissues", EXP NEUROL., vol. 24, 1969, pages 459 - 473, XP022980938, DOI: doi:10.1016/0014-4886(69)90149-6
COTTRELL FG.: "Application to the Cottrell equation to chronoamperometry", Z PHYSIK CHEM., vol. 42, 1902, pages 385
GABRIEL S; LAU RW; GABRIEL C.: "The dielectric properties of biological tissues: III. Parametric models for the dielectric spectrum of tissues", PHYS MED BIOL., vol. 41, 1966, pages 2271 - 2293, XP055052010
GODLEY PA.: "Prostate cancer screening: Promise and peril - a review", CANCER DETECT PREV., vol. 23, 1999, pages 316 - 324
GRIMMES S; MARTINSEN 0G.: "Electrolytics In Bioimpedance and Bioelectricity Basics. San Diego, CA", 2000, ACADEMIC PRESS
HALTER RJ; SCHNED A; HEANEY J; HARTOV A; SCHUTZ S; PAULSEN KD.: "Electrical impedance spectroscopy of benign and malignant prostatic tissues", J UROL., vol. 179, 2008, pages 1580 - 1586, XP022618578, DOI: doi:10.1016/j.juro.2007.11.043
KIMURA S; MORIMOTO T; UYAMA T; MONDEN Y; KINOUCHI Y; IRITANI T.: "Application of electrical impedance analysis for diagnosis of a pulmonary mass", CHEST, vol. 105, 1994, pages 1679 - 1682, XP008021754
KO HW; SMITH DG; SKURA JP: "In vitro measurements of brain edema with the magnetic bio-impedance method", PRESENTED AT THE ANNUAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY, 31 October 1996 (1996-10-31)
MAMALAKIS G; KAFATOS A; KALOGEROPOULOS N; ANDRIKOPOULOS N; DASKALOPULOS G; KRANIDIS A.: "Prostate cancer vs hyperplasia: relationships with prostatic and adipose tissue fatty acid composition", PROSTAGLANDINS LEUKOT ESSENT FATTY ACIDS, vol. 66, no. 5-6, May 2002 (2002-05-01), pages 467 - 477
MISTRY KISHOR; CABLE GREG: "Meta-Analysis of Prostate-Specific Antigen and Digital Rectal Examination as Screening Tests for Prostate Carcinoma", THE JOURNAL OF THE AMERICAN BOARD OF FAMILY PRACTICE, vol. 16, 2003, pages 95 - 101
PARKER SL; TONG T; BOLDEN S; WINGO PA.: "Cancer statistics", CA CANCER J CLIN., vol. 47, 1997, pages 5 - 27
SCARDINO PT.: "Early detection of prostate cancer", UROL CLIN NORTH AM., vol. 16, 1989, pages 635 - 655
SVETEC D; THOMPSON IM.: "PSA screening - current controversy", ANN ONCOL., vol. 9, 1998, pages 1283 - 1288
US BUREAU OF THE CENSUS POPULATION DIVISION. RESIDENT POPULATION OF THE UNITED STATES: ESTIMATES, BY AGE AND SEX, 21 March 2011 (2011-03-21), Retrieved from the Internet <URL:http://www.census.gov/population/estimates/nation/intfile2_1_.txt>
WINGO PA; LANDIS S; RIES LA.: "An adjustment of the 1997 estimate for new prostate cancer cases", CA CANCER J CLIN., vol. 47, 1997, pages 239 - 242
ZAPPA M; CIATTO S; BONARDI R; MAZZOTTA A.: "Overdiagnosis of prostate carcinoma by screening: An estimate based on the results of the Florence screening pilot study", ANN ONCOL., vol. 9, 1998, pages 1297 - 1300

Also Published As

Publication number Publication date
BR112013013619A2 (pt) 2016-09-13
WO2012076958A3 (fr) 2012-08-02

Similar Documents

Publication Publication Date Title
Kim et al. Sentinel lymph node mapping with pathologic ultrastaging: a valuable tool for assessing nodal metastasis in low-grade endometrial cancer with superficial myoinvasion
Csontos et al. Malnutrition risk questionnaire combined with body composition measurement in malnutrition screening in inflammatory bowel disease
Gaw et al. Bioimpedance in the assessment of unilateral lymphedema of a limb: the optimal frequency
Kassouf et al. P0 stage at radical cystectomy for bladder cancer is associated with improved outcome independent of traditional clinical risk factors
Koelmeyer et al. Body positional effects on bioimpedance spectroscopy measurements for lymphedema assessment of the arm
Peng et al. Potential biomarkers for early diagnosis of acute aortic dissection
Mahajan et al. Oxidative stress and its relationship with adenosine deaminase activity in various stages of breast cancer
Guerrios-Rivera et al. Is body mass index the best adiposity measure for prostate cancer risk? Results from a Veterans Affairs biopsy cohort
Muszynski et al. The impact of using electrical impedance spectroscopy (ZedScan) on the performance of colposcopy in diagnosing high grade squamous lesions of the cervix
Doll et al. Estimating hypoxic status in human tumors: a simulation using Eppendorf oxygen probe data in cervical cancer patients
de Abreu Bioimpedance and chronoamperometry as an adjunct to prostate-specific antigen screening for prostate cancer
US20210161388A1 (en) Method, system and speculum-free optical probe for optical assessment of cervix, and applications of same
WO2012076958A2 (fr) Procédé de criblage
US2247875A (en) Diagnostic method
US10386378B2 (en) Method of diagnosing prostate cancer by detecting chemical elements
Ianni Filho et al. Bioimpedance: New approach to non-invasive detection of liver fibrosis-a pilot study
Ratnakumari et al. A clinical study of parotid tumours
Yung et al. Transcutaneous computed bioconductance measurement in lung cancer: a treatment enabling technology useful for adjunctive risk stratification in the evaluation of suspicious pulmonary lesions
Lee et al. Wearable Graphene Tattoo Impedance Tomography for Skin Lesion Differentiation
Koelmeyer et al. Effects of Body Positioning When Assessing Lymphedema of the Lower Limb Using Bioimpedance Spectroscopy
Ahuja et al. Metastatic acral lentiginous melanoma: a case report and review
WO2013132001A1 (fr) Biomarqueurs de pronostic pour la survie post traitement d&#39;une maladie cancéreuse traitée par radiothérapie et/ou à chimiothérapie
RU2607949C1 (ru) Способ диагностики рака предстательной железы
JPH02189129A (ja) 生体インピーダンス測定装置
Huang et al. Electrical biopsy of irradiated intestinal tissue with a simple electrical impedance spectroscopy system for radiation enteropathy in rats—a pilot study

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 11831801

Country of ref document: EP

Kind code of ref document: A2

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 11831801

Country of ref document: EP

Kind code of ref document: A2

REG Reference to national code

Ref country code: BR

Ref legal event code: B01A

Ref document number: 112013013619

Country of ref document: BR

ENP Entry into the national phase

Ref document number: 112013013619

Country of ref document: BR

Kind code of ref document: A2

Effective date: 20130603