We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01466426
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Venous Thromboembolic Disease

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.


Study Design

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders
Study Start Date : November 2011
Primary Completion Date : December 2013
Study Completion Date : June 2014
Groups and Cohorts

Group/Cohort
DVT confirmed
DVT ruled out
PE confirmed
PE ruled out


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466426


Locations
Denmark
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
Investigators
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
ClinicalTrials.gov Identifier: NCT01466426     History of Changes
Other Study ID Numbers: NMA projekt K 59 PETVET
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014

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

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases