Clinical trial NCT00964275: Standard Diagnostic Procedures With or Without Fludeoxyglucose F 18 Positron Emission Tomography in Finding Cancer in Patients With a Blood Clot in a Vein
Official title: Study of Positron Emission Tomography With 18-fluorodeoxyglucose in Detecting Cancer in Patients With Idiopathic Venous Thromboembolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thromboembolism
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
thromboembolism
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2009-08-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Number of cancers diagnosed
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest - Hopital De La Cavale Blanche
Study officials:
affiliation: CHU Brest - Hopital De La Cavale Blanche
name: Pierre-Yves Salaun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robertson L, Broderick C, Yeoh SE, Stansby G. Effect of testing for cancer on cancer- or venous thromboembolism (VTE)-related mortality and morbidity in people with unprovoked VTE. Cochrane Database Syst Rev. 2021 Oct 1;10(10):CD010837. doi: 10.1002/14651858.CD010837.pub5.
citation: Robin P, Le Roux PY, Tromeur C, Planquette B, Prevot-Bitot N, Lavigne C, Pastre J, Merah A, Couturaud F, Le Gal G, Salaun PY. Risk factors of occult malignancy in patients with unprovoked venous thromboembolism. Thromb Res. 2017 Nov;159:48-51. doi: 10.1016/j.thromres.2017.08.021. Epub 2017 Sep 28.
citation: Robin P, Le Roux PY, Planquette B, Accassat S, Roy PM, Couturaud F, Ghazzar N, Prevot-Bitot N, Couturier O, Delluc A, Sanchez O, Tardy B, Le Gal G, Salaun PY; MVTEP study group. Limited screening with versus without (18)F-fluorodeoxyglucose PET/CT for occult malignancy in unprovoked venous thromboembolism: an open-label randomised controlled trial. Lancet Oncol. 2016 Feb;17(2):193-199. doi: 10.1016/S1470-2045(15)00480-5. Epub 2015 Dec 8.