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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:
ClinicalTrials.gov Identifier:
NCT00964275
First Posted: August 24, 2009
Last Update Posted: December 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Brest
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: August 21, 2009
First Posted: August 24, 2009
Last Update Posted: December 8, 2014
Last Verified: December 2014

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

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