Standard Diagnostic Procedures With or Without Fludeoxyglucose F 18 Positron Emission Tomography in Finding Cancer in Patients With a Blood Clot in a Vein (MVTEP)
|ClinicalTrials.gov Identifier: NCT00964275|
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : December 8, 2014
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.
|Condition or disease||Intervention/treatment|
|Thromboembolism Unspecified Adult Solid Tumor, Protocol Specific||Procedure: diagnostic procedure Radiation: fludeoxyglucose F 18|
- Demonstrate the efficacy, in terms of increased numbers of cancer diagnoses, of PET-CT with 18-FDG in patients with idiopathic venous thromboembolism.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Positron Emission Tomography With 18-fluorodeoxyglucose in Detecting Cancer in Patients With Idiopathic Venous Thromboembolism|
|Study Start Date :||March 2009|
|Primary Completion Date :||October 2014|
|Study Completion Date :||October 2014|
Experimental: Arm I
Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods.
Radiation: fludeoxyglucose F 18
PET with flueoxyglucose F 18
Active Comparator: Arm II
Patients only undergo standard diagnostic methods.
Procedure: diagnostic procedure
Standard diagnostic procedures followed
- Number of cancers diagnosed [ Time Frame: 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964275
|CHU Brest - Hopital De La Cavale Blanche|
|Brest, France, 29200|
|Principal Investigator:||Pierre-Yves Salaun, MD||CHU Brest - Hopital De La Cavale Blanche|