Evaluation of a New Imagingtechnologie for Thrombosis

NCT ID: NCT02469376

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-12-01

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.

Conditions

Abdominal Aortic Aneurysm; Deep Vein Thrombosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnosis with GP1

Injection and scanning of \[18F\]-GP1

Group Type: EXPERIMENTAL

[18F]-GP1

Intervention Type: DRUG

Radiopharmaceutical Product (Tracer) to visualize with Positron Emission Tomography a thrombus in humans.

Interventions

[18F]-GP1

Radiopharmaceutical Product (Tracer) to visualize with Positron Emission Tomography a thrombus in humans.

Intervention Type: DRUG

Other Intervention Names

GP1

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 < 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Life Molecular Imaging SA

INDUSTRY

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philipp A Kaufmann, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Nuclear Medicine

Locations

University Hospital Zurich, Division of Nuclear Medicine

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

PET - GP1_1

Identifier Type: -

Identifier Source: org_study_id