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CompletedNCT00964275MVTEPUpdated Dec 8, 2014

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

An interventional study of diagnostic procedure and fludeoxyglucose F 18 in Thromboembolism and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-08.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.
02

Conditions studied

  • Thromboembolism
  • Unspecified Adult Solid Tumor, Protocol Specific

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Keywords

  • unspecified adult solid tumor, protocol specific
  • thromboembolism
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In context

Thromboembolism

818 studies on the registry are indexed under Thromboembolism; 98 are open to participants now.

This study's enrollment of 400 is above the median of 196 across 436 interventional studies indexed under Thromboembolism.

Browse Thromboembolism studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (actual)

Study arms

  • Experimental
    Arm I

    Patients undergo diagnostic fludeoxyglucose F 18 PET in addition to standard methods.

    Radiation: fludeoxyglucose F 18

  • Active comparator
    Arm II

    Patients only undergo standard diagnostic methods.

    Procedure: diagnostic procedure

Interventions

  • Procedurediagnostic procedure

    Standard diagnostic procedures followed

  • Radiationfludeoxyglucose F 18

    PET with flueoxyglucose F 18

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What researchers measure

Primary outcomes

  1. Number of cancers diagnosed

    Time frame: 24 months

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Study locations

1 site
  • CHU Brest - Hopital De La Cavale Blanche
    Brest, 29200, France
08

References and documents

Publications

  • 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. PubMed 34597414 ↗
  • 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. PubMed 28978463 ↗
  • 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. PubMed 26672686 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00964275
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Aug 24, 2009
Start date
Mar 2009
Primary completion
Oct 2014
Completion
Oct 2014
Last update
Dec 8, 2014

Study contacts

Pierre-Yves Salaun, MD
principal investigator · CHU Brest - Hopital De La Cavale Blanche

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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