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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

— MVTEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964275
• Other study ID #: CDR0000639720
• Secondary ID: HCB-MVTEPRB 08-0
• Status: Completed
• Phase: N/A
• First received: August 21, 2009
• Last updated: December 5, 2014
• Start date: March 2009
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Thromboembolism
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• diagnostic procedure
Standard diagnostic procedures followed

Radiation:
• fludeoxyglucose F 18
PET with flueoxyglucose F 18

Locations

Country	Name	City	State
France	CHU Brest - Hopital De La Cavale Blanche	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cancers diagnosed		24 months	No