Evaluation of a New Imagingtechnologie for Thrombosis

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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

Primary Outcome

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

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

Condition

Abdominal Aortic Aneurysm

Intervention

[18F]-GP1

Study Arms / Comparison Groups

 Diagnosis with GP1
Description:  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 < 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Philipp A Kaufmann, Prof, ,

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations

NCT ID

NCT02469376

Organization ID

PET - GP1_1

Responsible Party

Sponsor

Study Sponsor

University of Zurich

Collaborators

 Life Molecular Imaging SA

Study Sponsor

Philipp A Kaufmann, Prof, Principal Investigator, University Hospital Zurich, Department of Nuclear Medicine

Verification Date

May 2017