JP2003511424A - Methods and apparatus for characterizing intravascular and other intraluminal lesions - Google Patents

Abstract

  (57) [Summary] Methods, devices, and kits for assessing luminal lesions are provided. The device includes an intraluminal detector capable of sensing radioactive or other labels. In this method, a detectable marker, either by introduction into the lumen itself or systemically into the patient's blood circulation, is introduced into the body lumen and localized to the lesion. The detector is introduced into the body lumen and the distribution of localized markers is detected in situ. This information is useful for a variety of purposes, such as identifying vulnerable plaque in patients with atherosclerotic disease.

Description

Detailed Description of the Invention

1. Field of the Invention The present invention relates generally to medical devices and methods. In particular, the present invention relates to devices and methods for intraluminal characterization of blood vessels and other lesions within body lumens.

Coronary artery disease, caused by the accumulation of atherosclerotic plaque in the coronary arteries, is one of the leading causes of death in the United States and in the world. Accumulation of plaque causes arterial stenosis. This condition is commonly referred to as a lesion, resulting in a decrease in blood flow to the myocardium (myocardial tissue). Myocardial infarction (more commonly known as a heart attack) can occur when an arterial lesion suddenly occludes a blood vessel to completely stop blood flow to the myocardium. Even when sudden occlusion does not occur, diminished blood flow can result in chronic blood flow deficit, which can cause significant tissue damage over time.

Various interventions have been proposed to treat coronary artery disease. Usually, the most effective treatment for disseminated lesions is coronary artery bypass grafting, which uses an external graft to bypass the lesion in the coronary artery in question. If the lesions are mild, drug treatment is often sufficient. Ultimately, the lesions of interest are often endovascularized by a variety of catheter-based approaches, including balloon angioplasty, atherectomy, radiation therapy, stent placement, and combinations of these approaches. Can be treated.

While various treatment techniques are available, cardiologists have the challenge of choosing the particular treatment that is best for their individual patient. Although numerous diagnostic aids have been developed, no single technology alone provides all the information necessary for treatment selection. Although angiography is very effective in locating lesions within the coronary vasculature, little information is available on the nature of the lesion. For more detailed characterization of lesions, intravascular ultrasound (IVUS), angiography, laser spectroscopy, computed tomography (CT), magnetic resonance imaging (MRI), etc. Various imaging techniques have been developed to obtain more detailed images. However, none of these techniques can completely determine the nature of the lesion. In particular, little information is available on whether the plaque is stable or unstable.

Plaques that form inside coronary arteries and other blood vessels contain inflammatory cells, smooth muscle cells, cholesterol, and fatty substances, which are usually the vascular endothelium and the underlying smooth muscle cells. Caught between. Various factors such as the thickness, composition and size of the deposited material characterize plaques as stable or unstable. Plaques are usually covered with a cap and / or an endothelial layer. Cap and /
Or, when the endothelial layer ruptures, the ruptured plaque releases a highly thrombogenic component that activates the coagulation cascade and rapidly induces a significant amount of coronary thrombosis. Such plaques are called unstable or “vulnerable”, and the resulting thrombus formation can result in variable neck pain, acute myocardial infarction (heart attack), sudden coronary death,
And may cause seizures. Recently, it has been proposed that plaque instability rather than the degree of plaque accumulation should be the primary determinant in treatment selection.

Various methods have been proposed for identifying whether a patient's plaque is stable or unstable. Among such proposals is a method to detect the slight increase in temperature caused by inflammation within vulnerable plaque. Another technique is to irradiate the plaque with infrared rays. It has also been proposed to label a substance with a radioisotope that is known by autoradiography to bind to stable and unstable plaques and use this substance. However, detecting radiolabels from outside the body greatly limits the sensitivity of this technique, making accurate localization of the lesion site difficult. Thus, there has been no technique with sufficient sensitivity and resolution needed to reliably characterize plaques at the cellular level in intact animals or humans.

For all these reasons, it would be desirable to provide improved methods and devices for identifying plaque stability or instability within coronary arteries and other vasculature. Moreover, it would be more desirable for such methods and techniques to be applicable to the characterization of lesions within other body lumens associated with other disease states. The methods and devices of the present invention are preferably used in situ, i.e., inside the body lumen to be evaluated, and because they effectively characterize disseminated disease, they are preferably used over relatively long distances. The cavity should be inspectable.
The method and device should be capable of sensitive detection so that even small differences between plaques or other lesions can be determined, and preferably without the need for prolonged device placement within the patient's body. , Should be able to evaluate in real time. At least some of these goals are believed to be achieved by the invention described below.

2. Description of the Background Art The use of radiolabeled substances for the detection of atherosclerotic lesions has been described in the medical literature. For example, Elmaleh et al. (1998) Proc. Natl.
Acad. Sci. USA 95: 691-695; Vallabhajosula and Fuster (1997) J. Nucl. Med. 38: 1788-1796); Demos et al. (19)
97) J. Pharm. Sci. 86: 167-171; Narula et al. (1995) Circulation 92:
474-484; Lees et al. (1998) Arterlosclerosis 8: 461-470. In U.S. Pat.No. 4,660,563, infusion of radiolabeled lipoproteins into a patient results in the incorporation of lipoproteins into atherosclerotic lesions within the patient and the use of external scintillation counters to detect these lesions early. It is described that it is possible. US Pat. No. 5,811,814 describes an intravascular radiation detection catheter. This catheter is used to detect labeled red blood cells, which can accumulate in aneurysms, for example. US Pat. No. 5,429,133 describes a laparoscopic probe for detecting radiation focused on solid tissue tumors. Small, Flexible Radiation Detector for Medical Uses Intra-Medical LLC (Santa Monica, CA, www.intra)
-Medical.com). U.S. Pat.No. 4,647,445; 4,877,599
See also: 4,937,067; 5,510,466; 5,711,931; 5,726,153; WO 89/10760.

SUMMARY OF THE INVENTION Characterization of lesions and other target sites in body lumens, particularly atherosclerotic lesions within a patient's vasculature, including coronary, peripheral and cerebrovascular structures. Methods, systems, and kits for doing so are provided. The invention is based on the introduction of a labeled marker, typically a radiolabeled marker, into a patient. Markers are in a format that allows or facilitates the assessment of target sites,
It is introduced so that it is localized at the lesion or target site. The introduction of the labeled marker can be systemic, eg, injected or infused into the patient's bloodstream to assess lesions in the vasculature or other luminal cavities in the body. Alternatively, it may be locally introduced, such as delivered directly to a target site within a blood vessel or other body lumen by a catheter. In addition, labeled markers can be introduced systemically and locally in various combinations. The labeled marker, after being introduced into the patient, is incorporated into the lesion or other target site, and then the amount of marker (accumulation), uptake, to facilitate or enable diagnosis or other assessment of the lesion. speed,
The distribution of markers, or other marker characteristics, is determined. In particular, according to the invention, the amount of marker at or near the lesion or other target site,
Uptake rates, and / or distributions are measured in situ using a detector introduced into the body lumen and placed in a known or measurable relative position to the lesion or other target site. .

Specific applications of the present invention include the diagnosis of lesions in the vasculature, particularly the diagnosis of coronary artery disease in the coronary vasculature. A wide range of other possible uses are possible, provided that they can be linked to lumen assessment. By introducing labeled cell precursors such as, for example, labeled amino acids, labeled nucleotides and labeled nucleosides, various conditions associated with excessive cell proliferation can be assessed and observed. For example, the presence or absence and prognosis of various luminal cancers such as bladder cancer, colon cancer, esophageal cancer, prostate cancer (including benign prostatic hypertrophy), lung cancer and other bronchial lesions can be evaluated.

There are a number of significant advantages to detecting labeled markers in situ within the body lumen. Such in situ detection enables detection of labels that cannot be detected from outside the body, such as visible light, fluorescence and luminescence. When using tissue-permeable labels, such as radioisotope irradiation, in situ detection is much more sensitive than in vitro detection. This is especially the case when using low energy (short path length) sources such as beta (β) radiation, conversion electrons and the like. The detection of low-energy radiation reduces the background observed when tracers are concentrated in adjacent organs or tissues and relies on, for example, the introduction of gamma (γ) -ray radiolabels and the use of gamma (γ) cameras in vitro. It is usually not suitable for detection. However, the present invention is not limited to the use of beta (β) rays, conversion electrons, and other short path length radiation, and any type of ionizing radiation can be used where appropriate.

In-situ detection also improves the detectability of the location and distribution of immobilized label within the body lumen. The detector is such that the immobilized radiation and other labels can be determined with an accuracy of less than 5 mm, usually less than 3 mm, preferably less than 2 mm, and often less than 1 mm along the axial direction of the body lumen. Expected to be configured and / or repositioned. The ability to accurately localize target sites such as vulnerable plaque sites and cell proliferation sites is of great benefit for subsequent treatment.

Labeled markers usually consist of at least two components, a detectable label and a binding agent. The detectable label can be any natural or synthetic material that allows in situ detection using an intravascular catheter or other intraluminal detector. Particularly suitable are radiolabels consisting of radionuclides that emit beta (β) rays, conversion electrons, and / or gamma (γ) rays. At present, preferred is a radioisotope which emits mainly beta (β) rays or conversion electrons, which has a relatively short path length and can more accurately confirm the position of a target site or a target substance. In certain embodiments, it may be desirable to use markers or radiolabels that emit both beta and gamma radiation. In such an embodiment, by using a detector that can quantify both beta (β) and gamma (γ) radiation, the observed beta (β) / gamma (γ) radiation ratio and known release characteristics of the label Based on and, one can measure how close the detector is to the label. That is, the relative decrease in beta (β) radiation observed means that the detector is away from the label.

In addition to radiolabels, other visible markers, chemiluminescent labels, and / or bioluminescent labels, including fluorescent labels such as fluorescein, Texas Red, phycocyanin dyes, allyl cyanine sulfonate dyes, can also be used in the present invention. In the present invention,
Passive labels that respond to the search in a variety of ways can also be used. For example, the label may consist of a paramagnetic or superparamagnetic substance detected by magnetic resonance. Alternatively, it may be a label that is acoustically echoed or absorbed so that it can be detected by ultrasonic echoes. Further, it may be a label that absorbs or reflects infrared light so that it can be detected by optical coherence tomography. Still further, it may be a label that is activated or fluoresces in the presence of a suitable source of excitation energy.

The label is generally attached to the binding substance by a covalent bond or a non-covalent bond. The binding substance may be substantially any substance as long as it is a substance that is taken up and / or bound to a desired intraluminal target site. Thus, for detecting and labeling atherosclerotic lesions in blood vessels, the substance may be a natural substance that is taken up by the lesion, such as low density lipoprotein or components thereof. In the case of excessive self-proliferation, various cell precursors such as proteins and nucleic acids may be used as the binding substance. The binding substance may be a natural substance incorporated into a growing or proliferating target site, or may be prepared or synthesized so as to specifically bind at a target position of the target site. For example, antibodies can be made to a wide range of vascular or non-vascular target sites. Moreover, in some cases, natural receptors and / or ligands can be used for specific target sites. For example, the monocyte chemoattractant peptide I (MCPI) localizes to receptors that are upregulated by macrophages in plaques. Other target substances in plaques include lectins whose receptors are upregulated on endothelial cells that cover plaques. Z2D3 (
Antibodies such as Khaw et al., Carrio et al., Narula et al.) Localize on smooth muscle growing in plaques. Another substance is fluorine-18 labeled fluorodeoxyglucose. It is known that this substance emits positrons, is used as an energetic substance by macrophages and monocytes, and exhibits strong localization in experimental models of atherosclerosis. Also included are tissue factors, substances that bind to lymphocyte surface antigens or secreted substances, and other secreted proteins that are trapped within vulnerable plaques and are characteristic of those plaques.

The labeling substance and the binding substance can be bound to each other by any conventional method. Most commonly, the components of the labeling substance and / or the binding substance are derivatized to allow covalent attachment. Covalent attachment is usually direct, although in some cases binding members can be used. For non-covalent binding, various non-covalent linkers such as biotin, avidin, intermediate antibody, receptor and ligand can be used. A variety of suitable conjugation techniques are described in Nature Biotechnology (1999), the entire disclosure of which is incorporated herein by reference.
This is explained in the review article on pages 849-850 of Vol.

A variety of suitable labeled markers are presented in the medical and scientific literature. For example, U.S. Pat.Nos. 4,647,445, 4,660,563, 4,937,067, 4,877,599, 5,510,466, 5,711,931, 5,726,153, and WO 89/1076.
See 0. These patents are fully incorporated herein by reference.

An important aspect of the invention is that the label can be detected and / or imaged in situ after it has been localized to the vessel wall or other body lumen. Since the label binds to a specific labeling substance in the body lumen, the localization pattern of the label matches the pattern of the target substance in the body lumen. Such separate detection can be carried out simultaneously, sequentially and optionally in combination. For example, if the labeled marker consists of low density lipoprotein, or a component thereof, the labeled marker will bind to atherosclerotic plaques that are actively proliferating or accumulating and are therefore at risk of destabilization. Thus, the pattern of markings is consistent with the unstable plaque pattern within the patient's vasculature.

Detection of the label and its pattern within the body lumen is performed using an intraluminal detector. The detector is usually a detector capable of detecting the ionizing radiation emitted from the radioisotope label within a certain distance of the label, as described in more detail below. The detector and catheter can be introduced into the body lumen by a variety of conventional techniques.
In the case of an intravascular detector, a percutaneous technique such as the Seldinger method of introducing a guide wire using a needle and a sheath is preferable. Alternatively, the vessel may be accessed by surgical incision, and a variety of other surgical and minimally invasive techniques may be used to introduce the endoluminal detector into other body lumens.

The nature of the label and the characteristics of the detector are such that the signal generated by the label is within a certain distance, usually within 5 mm, preferably within 3 mm, and in some cases within 1 mm from the detection surface or the detection component of the detector. Only selected to be visible or detectable. That is, only the detector should have a limited viewing area for observing the localized label, so that background emitted from the label at a location remote from the detector is not detected. With this method, the position of the label can be accurately detected. In a presently preferred embodiment, the label emits beta (β) rays or conversion electrons or low energy X-rays with very short path lengths. The sensitivity of the detector is chosen such that beta (β) rays are observed only at very short distances, typically less than 3 mm, preferably less than 1 mm. In addition, the detector may be configured such that the detection surface or component is in direct contact with the wall of a blood vessel or other body lumen to enhance the detectability of the charged particle radiation.

In a particular aspect of the present invention, the detection of the label is such that the ability to distinguish lesions present at 3 mm intervals can characterize changes in pathogenic sites within a body lumen over a minimum distance. Done over distance. For example, in the case of blood vessels, the invention is typically used to image blood vessels over a distance of at least 30 mm, preferably at least 40 mm, more preferably at least 50 mm. To make such a detection, the detector may be scanned over a distance within a blood vessel or other body lumen. However, preferably, the detector remains stationary within the lumen so that it has spatial resolution over the aforementioned preferred minimum distance without moving the detector itself.

In addition to the aforementioned minimum detection distance, the detector is preferably isotropic over at least its perimeter or perimeter. Regardless of whether the detector is scanned or stationary during detection, it will usually be preferable to perform detection of the label over the entire perimeter or perimeter of the body lumen. However, it may be desirable in some cases to desire a directional scan or observation of a particular radial region of the body lumen wall.

In order to determine the spatial distribution of two or more substances within a body lumen, it may be preferable to detect them separately using two or more labels. For example, in plaques at different stages of development, smooth muscle proliferation (Z2D3
By the localization of the antibody), degree of macrophage infiltration (detectable by MCPI), metabolic level of the macrophage (detectable by FDG metabolic substrate) and activity of metalloproteinase (by labeled antibody specific for metalloproteinase) Detectable) are different. Two or more parameters are evaluated simultaneously if each radiopharmaceutical has a radiolabel that differs substantially in energy from one another, or if one radionuclide has a substantially shorter half-life than the other. be able to. Alternatively, labels with different properties, such as luminescence, fluorescence, and / or radioisotope emission, can be used and detected simultaneously with minimal interference.

By detecting localized markers, useful information regarding lesions or other structural states of body lumens can be obtained. As mentioned above, the present invention allows the distribution of target substances within a body lumen to be determined axially and circumferentially. In the case of atherosclerotic lesions within blood vessels, this information is particularly suitable for assessing the need for treatment and planning for specific treatment modalities. It is believed that the present invention is particularly capable of identifying relatively small lesions, eg, with less than 50% luminal obstruction, but lesions that are unstable and require immediate intervention. Conversely, large lesions (greater than 50% occlusion) can be identified with stable and low need for immediate intervention.

Although the present invention is directed to intraluminal marker detection, the extracorporeal detection of the same or other markers and / or the extracorporeal detection and imaging of catheters used for intraluminal detection. It is also possible to use it in combination with In vitro detection of immobilized markers may be useful for pre-positioning an intraluminal detection catheter and / or comparing information from different markers and targets (
Each marker can be bound to different binding substances with different specificities). In vitro detection of catheters will enable mapping of vasculature or other luminal systems. The location of the catheter can be fluoroscopically detected by MRI or other methods, and the location of the lesion detected in the body can be shown in an image or map created by extracorporeal detection.

The present invention further provides a radiation detection device comprising an elongated body, typically a catheter, and a radiation detector attached to the elongated body. The catheter or other elongated body is configured to access the interior of a target body lumen such as a blood vessel, ureter, urethra, esophagus, cervix, uterus, bladder. The radiation detector is capable of sensing radiation emitted within the body lumen and incident along the elongated body.
In a first specific embodiment, the radiation detector is capable of sensing radiation over a length of at least 3 cm, preferably at least 4 cm, more preferably at least 5 cm. Optionally, the radiation detector is isotropically sensitive to radiation and preferably has equal sensitivity over all radial directions around the elongated body.

As a second specific embodiment, the radiation detector of the present invention is capable of distinguishing radiation emitted from at least two different radiolabels having different threshold levels of energy.

As a third specific embodiment, the radiation detector of the present invention moves in the body in the axial direction and has a length of at least 3 cm, preferably at least 4 cm, more preferably at least 5 cm.
It is capable of sensing radiation incident along the body along its length. Normal,
Such devices include a catheter having a barrel that can rest within a vessel and an internal detector that can move axially within the barrel that is stationary. Alternatively, the entire catheter may be moved within the lumen to reach the desired length.

Optionally, the catheter may consist of two or more different detection systems. Thus, catheter may mean, in addition to label detection systems, also optical, ultrasound, OCT, MR or other types of imaging systems. This allows "registered" image information from the catheter,
Alternatively, it is also possible to correlate it with the characteristic of the lesion detected by the catheter. In some cases, it may be useful to excite the first or second label immobilized at the target site with a catheter.

Still further, the invention includes a kit for identifying or evaluating a luminal lesion or other target site. The kit includes a radiation detector configured for introduction into a body lumen and instructions for use according to any of the methods described above.

Alternatively, the kit according to the present invention comprises a radiation detector configured to be introduced into a body lumen, a substance capable of binding to a target substance in the body lumen, and a detectable label bound to the substance. It may include a container that contains the reagent that contains it, and a package that holds the radiation detector and the container together. The container is a box, tray, tube,
It may be any conventional container such as a pouch. Instructions for use are typically provided in the accompanying package insert, but may be printed in whole or in part on the package itself. Usually, the radiation detector is kept sterile in the package.

While the above is a complete description of the preferred embodiments of the present invention, it is also possible to use various alternatives, modifications and equivalents. Therefore, the above description should not be taken as limiting the scope of the invention, which is defined by the appended claims.

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE), OA (BF, BJ , CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, K E, LS, MW, MZ, SD, SL, SZ, TZ, UG , ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, BZ, C A, CH, CN, CR, CU, CZ, DE, DK, DM , DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, K E, KG, KP, KR, KZ, LC, LK, LR, LS , LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, PL, PT, RO, R U, SD, SE, SG, SI, SK, SL, TJ, TM , TR, TT, TZ, UA, UG, UZ, VN, YU, ZA, ZW (72) Inventor Strauss H. William             United States Redo, California             Wood City Summit Ridge             Wraith 45 F-term (reference) 4C085 HH03 KA29 LL07

Claims (43)

[Claims] 1. A method for identifying or assessing a luminal lesion comprising the steps of:
Introducing a first detectable marker into a body lumen, wherein said marker is localized to a lesion comprising a substance that preferentially binds to or preferentially incorporates the detectable marker; Introducing a detector into the body lumen; and using the detector to detect localized markers. 2. The method of claim 1, wherein introducing the detectable marker comprises introducing a radioactive marker. 3. The method of claim 2, wherein the step of introducing a radioactive marker comprises introducing a radioisotope that emits beta (β) radiation. 4. The method of any one of claims 1-3, wherein the step of introducing a detectable marker comprises systemic introduction of the marker. 5. The method according to any one of claims 1 to 3, wherein the step of introducing a detectable marker comprises local introduction through a detector. 6. The method of any one of claims 1-3, wherein the step of introducing a detectable marker comprises systemicity to the vasculature of the patient. 7. The method of claim 1, wherein introducing the detector comprises percutaneously introducing a catheter comprising the detector into a body lumen. 8. The step of introducing a detector comprises surgically accessing a body lumen to create an access path and advancing a catheter comprising the detector through the path and into the body lumen. The method described in 1. 9. The step of detecting a localized marker is performed by 5 mm on the detection surface of the detector.
The method of claim 1, comprising detecting the marker within. 10. The marker emits beta (β) radiation and the detector emits beta (β) radiation.
) The method of claim 1, wherein the line is detected. 11. The method of detecting localized markers comprises scanning a segment of a body lesion having a length of at least 3 cm.
The method according to any one of 10. 12. The method of claim 11, wherein the scanning length is at least 4 cm. 13. The method of claim 11, wherein scanning the segment comprises locating a detector with a detection surface and scanning while the detector is stationary within the body lumen. the method of. 14. The method of claim 11, wherein scanning the segment comprises determining the position of the detector and changing the position of the detector to scan the entire segment. 15. The method of detecting a localized marker comprises isotropically detecting a marker attached around the periphery of a body lumen.
The method according to any one of 1. 16. The method of claim 1, further comprising the step of: introducing a second detectable marker into the body lumen, wherein the second detectable marker is the second detection. Localizing in the lesion containing a second substance that preferentially binds to the possible marker; and detecting a second detectable marker. 17. The method of claim 16, wherein the second detectable marker is detected using the same detector used to detect the first detectable marker. 18. The method of claim 16, wherein the second detectable marker is detected using a second detector. 19. A method for evaluating the stability of an intravascular lesion, which comprises the steps of: introducing a radiolabeled substance into a blood vessel, wherein the marker is selectively applied to plaques at high risk of rupture. Uptake; introducing a detector into the blood vessel; and determining the degree of uptake of the radiolabeled substance into the lesion, where the determination can assess the stability of the lesion. 20. The method of claim 19, wherein the step of introducing the radiolabeled substance comprises the introduction of a radioisotope that emits beta (β) rays. 21. The method according to either claim 19 or 20, wherein the step of introducing the radiolabeled substance comprises systemic introduction of the marker. 22. The method according to either claim 19 or 20, wherein the step of introducing the radiolabeled substance comprises local introduction through a detector. 23. The method of any of claims 19 or 20, wherein the step of introducing the radiolabeled substance comprises systemic injection into the vasculature of the patient. 24. The method of claim 19, wherein introducing the detector comprises percutaneously introducing a catheter comprising the detector into a blood vessel. 25. The method of claim 19, wherein introducing a detector comprises surgically accessing a blood vessel to create an access path and advancing a catheter comprising the detector through the path. . 26. The method of claim 19, wherein the step of determining the degree of incorporation comprises detecting the radiolabeled material within 5 cm of the detection surface of the detector. 27. The method of claim 26, wherein the radiolabelled material emits beta (β) radiation and the detector detects beta (β) radiation. 28. The method of claim 19, wherein the step of determining the degree of uptake comprises scanning a segment of a body lesion having a length of at least 3 cm.
The method according to any one of 27. 29. The method of claim 28, wherein the scanning length is at least 4 cm. 30. The method of claim 28, wherein scanning the segment comprises determining a position of the detector with a detection surface and scanning while the detector is stationary within the body lumen. The method described. 31. The method of claim 28, wherein scanning the segment comprises determining the position of the detector and changing the position of the detector to scan the entire segment. 32. The method of determining the degree of uptake comprises isotropically detecting a marker attached around the periphery of a body lumen, 19, 26, and
The method according to any one of 27. 33. The method of claim 19, further comprising the step of: introducing a second radiolabeled substance into the blood vessel, wherein the second radiolabeled substance is preferential to the lesion. Localized to the lesion comprising a second substance that binds chemically; and detecting a second radiolabeled substance. 34. The method of claim 33, wherein the second radiolabeled substance is detected using the same detector used to detect the first radiolabeled substance. 35. The method of claim 33, wherein the second radiolabeled substance is detected using a second detector. 36. A radiation detection apparatus comprising: an elongated body portion configured to access a body lumen; and a radiation detector on the elongated body portion, the elongated body portion extending over a length of at least 3 cm. A radiation detector for sensing radiation incident along. 37. The radiation detector of claim 36, wherein the radiation detector isotropically senses radiation on the elongated body. 38. A radiation detection device comprising: an elongated body portion configured to access a body lumen; and a radiation detector on the elongated body portion, the radiation detector emitting at least two different radiolabels. A device provided with a radiation detector that can identify the radiation that is generated. 39. The radiation detection device according to claim 38, wherein the radioactive label includes a β-ray emitting radioisotope and a γ-ray emitting radioisotope. 40. A radiation detection device, comprising: an elongated body configured to access a body lumen; and a radiation detector on the elongated body, wherein the radiation detector axially moves within the body at least. 5c
A radiation detector capable of sensing radiation incident along an elongated body over a length of m. 41. A kit comprising: A radiation detector configured for introduction into a body lumen; and 20. Instructions for use according to any of claims 1 or 19. 42. A kit comprising: a radiation detector configured for introduction into a body lumen; a container containing a reagent comprising a substance capable of binding to a target within the body lumen and a radiolabel attached to the substance. And a package containing the radiation detector and the container. 43. A method of identifying an intravascular lesion or accessing an intravascular lesion comprising the steps of: providing data indicating a localized accumulation of a detectable marker at a vascular site. , Accumulation indicating a disease state; and, based on the data, determining whether the target site consists of vulnerable plaques.