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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Søren Hess, MD, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01466426
First received: November 3, 2011
Last updated: November 7, 2011
Last verified: October 2011

November 3, 2011
November 7, 2011
November 2011
December 2012   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01466426 on ClinicalTrials.gov Archive Site
Not Provided
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The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders (The PETVET Study)
The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

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.

Venous Thromboembolic Disease
Not Provided
  • DVT confirmed
  • DVT ruled out
  • PE confirmed
  • PE ruled out
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact: Soeren Hess, MD +45 21 54 22 47 hess@dadlnet.dk
Denmark
 
NCT01466426
NMA projekt K 59 PETVET
No
Søren Hess, MD, Odense University Hospital
Odense University Hospital
Not Provided
Study Chair: Soeren Hess, MD Odense University Hospital
Study Chair: Poul Henning Madsen, MD Odense University Hospital
Odense University Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP