Evaluation of a New Imagingtechnologie for Thrombosis

NCT02469376 | Terminated Phase 1

• 1 other identifier: PET - GP1_1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Aortic Aneurysm; Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Calculation of the effective dose to the patient according to the tissue distribution data of [18F]-GP1 (Dosimetry)

  12 Months

Study Arms (1)

Diagnosis with GP1

EXPERIMENTAL

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

Drug: [18F]-GP1

Interventions

[18F]-GP1 DRUG

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

Also known as: GP1

Diagnosis with GP1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Life Molecular Imaging SA: collaborator

Study Sites (1)

University Hospital Zurich, Division of Nuclear Medicine

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Venous Thrombosis

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Thrombosis; Embolism and Thrombosis

Study Officials

• Philipp A Kaufmann, Prof

  University Hospital Zurich, Department of Nuclear Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2015
• First Posted: June 11, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

CH (1)