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

This study has been completed.
Information provided by (Responsible Party):
Søren Hess, MD, Odense University Hospital Identifier:
First received: November 3, 2011
Last updated: October 26, 2014
Last verified: October 2014
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.

Venous Thromboembolic Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders

Further study details as provided by Søren Hess, MD, Odense University Hospital:

Primary Outcome Measures:
  • Proof-of-concept [ Time Frame: During diagnostic workup ]
    Simple assessment of scans - positive or negative in the relevant patient categories

Enrollment: 40
Study Start Date: November 2011
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
DVT confirmed
DVT ruled out
PE confirmed
PE ruled out

Detailed 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.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population comprises the following patient groups: 10 patients with a positive diagnosis of DVT, 10 patients where clinically suspected DVT was ruled out, 10 patients with a positive diagnosis of PE, and 10 patients where clinically suspected PE was ruled out.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01466426

Dept. of Acute Medicine, Odense University Hospital
Odense, Denmark, dk-5000
Dept. of Nuclear Medicine, Odense University Hospital
Odense, Denmark, dk-5000
Dept. of Respiratory Medicine, Odense University Hospital,
Odense, Denmark, dk-5000
Sponsors and Collaborators
Odense University Hospital
Study Chair: Soeren Hess, MD Odense University Hospital
Study Chair: Poul Henning Madsen, MD Odense University Hospital
  More Information

Responsible Party: Søren Hess, MD, MD, Odense University Hospital Identifier: NCT01466426     History of Changes
Other Study ID Numbers: NMA projekt K 59 PETVET
Study First Received: November 3, 2011
Last Updated: October 26, 2014

Keywords provided by Søren Hess, MD, Odense University Hospital:
Venous thromboembolic disease
Deep veinous thrombosis
Pulmonary embolism

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases processed this record on May 25, 2017