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The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders (The PETVET Study)

O

Odense University Hospital

Status

Completed

Conditions

Venous Thromboembolic Disease

Study type

Observational

Funder types

Other

Identifiers

NCT01466426
NMA projekt K 59 PETVET

Details and patient eligibility

About

This pilot study aims at validating 18F-flourodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) in the detection and characterization of venous thromboembolism (VTE) in the entire human body, especially deep venous thrombosis (DVT) and pulmonary embolism (PE). On completion of this study the investigators will hopefully be able to demonstrate the importance of functional/molecular imaging technique in managing patients with this common and potentially fatal disorder.

Full description

Acute DVT and PE are common and serious conditions. Highly effective treatment (most often anticoagulant agents) is available for acute VTE, but it is associated with potentially dangerous side effects. In addition, DVT and PE are just two manifestations of VTE, which can occur everywhere in the human organism. An underlying disease (i.e. cancer) is often a key factor in developing VTE.

Commonly used diagnostic imaging techniques in DVT and PE have a fair diagnostic accuracy, but do not address other important aspects of the disease. In contrast to this, FDG-PET/CT has the potential to contribute in VTE diagnosis by

  • Differentiate between acute and chronic VTE
  • Screening of the entire body for VTE (e.g. the pelvis where normal imaging techniques fail)
  • Early diagnosis of underlying disease (e.g. cancer, with the possibility of early treatment)

This is a pilot study with the above mentioned objectives, and is part of a larger study addressing other aspects of FDG-PET/CT in VTE.

The investigators believe that their hypothesis that FDG-PET/CT imaging may introduce a new approach for detecting thrombi anywhere in the body, particularly in the venous system including the pelvis and the calves, will add a new dimension in treating patients with suspected PE. This technology will only detect acute thrombi and not chronic thrombi that no longer have activity, which will obviate unnecessary treatment in this population.

Enrollment

40 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Positive or negative diagnosis of VTE (DVT/PE)
  • Age ≥ 50 years
  • Informed consent obtained
  • Symptoms < 1 week

Exclusion criteria

  • Pregnant or lactating women
  • Foreign language patients with a need for an interpreter
  • Previous DVT or PE
  • Known malignancy

Trial design

40 participants in 4 patient groups

DVT confirmed
DVT ruled out
PE confirmed
PE ruled out

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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