Standard Diagnostic Procedures With or Without Fludeoxyglucose F 18 Positron Emission Tomography in Finding Cancer in Patients With a Blood Clot in a Vein

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of Positron Emission Tomography With 18-fluorodeoxyglucose in Detecting Cancer in Patients With Idiopathic Venous Thromboembolism

Conditions
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Thromboembolism, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: diagnostic procedure
* Radiation: fludeoxyglucose F 18


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of idiopathic venous thromboembolism (IVTE) meeting 1 of the following criteria: Newly diagnosed Recurrent disease controlled by anticoagulant therapy No IVTE caused by a reversible major risk factor No IVTE caused by a major constitutional risk factor, including any of the following: Antiphospholipid antibody syndrome Antithrombin deficit Protein C Protein S PATIENT CHARACTERISTICS: Not pregnant No other known active cancer at the onset of IVTE

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods. | Radiation: fludeoxyglucose F 18<br>* PET with flueoxyglucose F 18<br>|
| Active Comparator: Arm II<br>Patients only undergo standard diagnostic methods. | Procedure: diagnostic procedure<br>* Standard diagnostic procedures followed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cancers diagnosed |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific, thromboembolism