Evaluation of a New Imagingtechnologie for Thrombosis (PET-GP1_1)

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

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.

Study Overview

• Status: Terminated
• Conditions: Deep Vein Thrombosis; Abdominal Aortic Aneurysm
• Intervention / Treatment: Drug: [18F]-GP1

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Division of Nuclear Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Life Molecular Imaging SA
• Investigators: Principal Investigator: Philipp A Kaufmann, Prof, University Hospital Zurich, Department of Nuclear Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Aortic Diseases; Thrombosis; Venous Thrombosis; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: PET - GP1_1