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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00964275
First received: August 21, 2009
Last updated: September 29, 2009
Last verified: August 2009
  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
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 National Cancer Institute (NCI):

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

Estimated Enrollment: 310
Study Start Date: March 2009
Estimated Primary Completion Date: March 2011 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964275

Locations
France
CHU Brest - Hopital De La Cavale Blanche Recruiting
Brest, France, 29200
Contact: Pierre-Yves Salaun, MD    33-2-9822-3333      
Sponsors and Collaborators
CHU Brest - Hopital De La Cavale Blanche
Investigators
Principal Investigator: Pierre-Yves Salaun, MD CHU Brest - Hopital De La Cavale Blanche
  More Information

Additional Information:
No publications provided

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: September 29, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
thromboembolism

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on April 16, 2014