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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT00964275
First received: August 21, 2009
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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 Intervention
Thromboembolism
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: diagnostic procedure
Radiation: fludeoxyglucose F 18

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study of Positron Emission Tomography With 18-fluorodeoxyglucose in Detecting Cancer in Patients With Idiopathic Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Number of cancers diagnosed [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: March 2009
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964275

Locations
France
CHU Brest - Hopital De La Cavale Blanche
Brest, France, 29200
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Pierre-Yves Salaun, MD CHU Brest - Hopital De La Cavale Blanche
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT00964275     History of Changes
Other Study ID Numbers: CDR0000639720, HCB-MVTEP, RB 08-062, INCA-RECF0945, EUDRACT-2008-004135-38
Study First Received: August 21, 2009
Last Updated: October 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
unspecified adult solid tumor, protocol specific
thromboembolism

Additional relevant MeSH terms:
Thromboembolism
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Fluorodeoxyglucose F18
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals

ClinicalTrials.gov processed this record on November 27, 2014