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

Not Applicable

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Thromboembolism
• Interventions: Procedure: diagnostic procedure; Radiation: fludeoxyglucose F 18

• Registration Number: NCT00964275
• Lead Sponsor: University Hospital, Brest

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-08-21
• Study First Submitted QC: 2009-08-21
• Study First Posted: 2009-08-24
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II	diagnostic procedure	Patients only undergo standard diagnostic methods.
Arm I	fludeoxyglucose F 18	Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods.

Primary Outcome Measures

Name	Time	Method
Number of cancers diagnosed	24 months

Trial Locations

Locations (1)

CHU Brest - Hopital De La Cavale Blanche; 🇫🇷 Brest, France