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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00964275

Acronym

MVTEP

Enrollment

400

Registered

2009-08-24

Start date

2009-03-31

Completion date

2014-10-31

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific, thromboembolism

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.

Interventions

PROCEDUREdiagnostic procedure

Standard diagnostic procedures followed

RADIATIONfludeoxyglucose F 18

PET with flueoxyglucose F 18

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Number of cancers diagnosed	24 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026