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Completed

NCT Number: NCT01466426

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Acute Medicine, Odense University Hospital, Odense, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proof-of-concept

    Time frame: During diagnostic workup

    Simple assessment of scans - positive or negative in the relevant patient categories

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Acronym: PETVET

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 8, 2011
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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