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Clinical Trial Summary

RATIONALE: Diagnostic procedures, such as fludeoxyglucose F 18 positron emission tomography, may help find and diagnose cancer. It is not yet known whether standard diagnostic procedures are more effective when given with or without fludeoxyglucose F 18 positron emission tomography in finding cancer.

PURPOSE: This randomized clinical trial is studying fludeoxyglucose F 18 positron emission tomography given together with standard diagnostic procedures to see how well it works compared with standard diagnostic procedures alone in finding cancer in patients with a blood clot in a vein.


Clinical Trial Description

OBJECTIVES:

Primary

- Demonstrate the efficacy, in terms of increased numbers of cancer diagnoses, of PET-CT with 18-FDG in patients with idiopathic venous thromboembolism.

Secondary

- Assess the risk of cancer detected at 1 year.

- Assess whether PET allows earlier detection of cancer.

- Evaluate survival.

OUTLINE: This is a multicenter study.

All patients undergo standard (clinical and biological) diagnostic tests for cancer. Patients are randomized to 1 of 2 diagnostic arms.

- Arm I: Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods.

- Arm II: Patients only undergo standard diagnostic methods. Patients are followed up for 2 years. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00964275
Study type Interventional
Source University Hospital, Brest
Contact
Status Completed
Phase N/A
Start date March 2009
Completion date October 2014

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