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| Name | Class |
|---|---|
| Lantheus Biosciences Ltd. | INDUSTRY |
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Arterial and venous thrombi play an important role in various vascular diseases such as myocardial infarction, stroke, transient ischemic attacks (TIA) and pulmonary embolism. These thromboembolic disorders are the leading causes of morbidity and mortality worldwide. A non-invasive method for the quantitative and effective detection of thrombi in the whole body has not yet been established. In spite of the available techniques, 30% to 40% of ischemic strokes "cryptogenic" (undetermined cause, the source of thromboembolism is never identified). Possible causes of cryptogenic stroke atherosclerosis include in the aortic arch or intracranial arteries. A plaque in the arch or other large vessels could be an important source of cryptogenic strokes, however, are those difficult to detect by routine methods. The approach of thrombus targeted molecular imaging could identify potentially troublesome plaques early on before they become a dangerous rupture. The hypothesis is that the radiotracer 18F-arterial GP1 and venous thrombi using positron emission tomography (PET) can be made visible. The primary goal is the potential applicability of the substance as a PET tracer for diagnosing thrombi.
This is a first in man study with which we are testing the feasibility of the use of this radiopharmaceutical product to visualize a thrombus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnosis with GP1 | Experimental | Injection and scanning of [18F]-GP1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]-GP1 | Drug | Radiopharmaceutical Product (Tracer) to visualize with Positron Emission Tomography a thrombus in humans. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of biodistribution of [18F]-GP1 and its properties as a PET imaging agent for detection of abdominal aortic aneurysm (AAA) and deep vein thrombosis (DVT). | Biodistribution and diagnostic properties of the new Tracer | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Calculation of the effective dose to the patient according to the tissue distribution data of [18F]-GP1 (Dosimetry) | Dosimtery assessment of the new Tracer | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp A Kaufmann, Prof | University Hospital Zurich, Department of Nuclear Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Division of Nuclear Medicine | Zurich | Canton of Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| D001018 |
| Aortic Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |