Evaluation of a New Imagingtechnologie for Thrombosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Biodistribution, Imaging Properties, and Radiation Dosimetry of [18F]-GP1 Positron Emission Tomography (PET) Tracer in Vascular Disease Imaging

Conditions
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Abdominal Aortic Aneurysm, Deep Vein Thrombosis

Intervention / Treatment
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* Drug: [18F]-GP1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with AAA (diameter >3.5cm in duplex sonography) or acute DVT. Male and female patients 18 years and older, Signed Informed Consent after being informed Exclusion Criteria: contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, women who are pregnant or breast feeding, women with the intention to become pregnant during the course of the study, other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease), renal clearance < 30 mL/min known or suspected non-compliance, drug or alcohol abuse, inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject, participation in another study with an investigational drug during the present study and 7 days thereafter. enrolment of the investigator, his family members, employees and other dependent persons last systemic treatment with GP IIb/IIIa antagonists should not have been applied within 48 h before performing study exam

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnosis with GP1<br>Injection and scanning of [18F]-GP1 | Drug: [18F]-GP1<br>* Radiopharmaceutical Product (Tracer) to visualize with Positron Emission Tomography a thrombus in humans.<br>* Other names: GP1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |