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Evaluation of a New Imagingtechnologie for Thrombosis

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Disease Information

Descriptive Information
Brief Title † Evaluation of a New Imagingtechnologie for Thrombosis
Official Title † Biodistribution, Imaging Properties, and Radiation Dosimetry of [18F]-GP1 Positron Emission Tomography (PET) Tracer in Vascular Disease Imaging
Brief Summary 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 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.
Study Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † 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).
Secondary Outcome Measure † Calculation of the effective dose to the patient according to the tissue distribution data of [18F]-GP1 (Dosimetry)
Condition † Abdominal Aortic Aneurysm Deep Vein Thrombosis
Intervention † Drug[18F]-GP1
Study Arms / Comparison Groups Diagnosis with GP1 Injection and scanning of [18F]-GP1
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 4
Start Date † September 2014
Completion Date December 1, 2016
Primary Completion Date December 1, 2016
Eligibility Criteria † 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
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Switzerland
Administrative Information
NCT ID † NCT02469376
Organization ID PET - GP1_1
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † University of Zurich
Collaborators †† Piramal Imaging SA
Investigators † Principal Investigator: Philipp A Kaufmann, Prof, University Hospital Zurich, Department of Nuclear Medicine
Information Provided By
Verification Date May 2017
First Received Date † June 8, 2015
Last Updated Date May 8, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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