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
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466426

Contacts
Contact: Soeren Hess, MD +45 21 54 22 47 hess@dadlnet.dk

Locations
Denmark
Dept. of Acute Medicine, Odense University Hospital Recruiting
Odense, Denmark, dk-5000
Contact: Jens Jørgen Frifeldt, MD         
Dept. of Nuclear Medicine, Odense University Hospital Recruiting
Odense, Denmark, dk-5000
Contact: Soeren Hess, MD         
Dept. of Respiratory Medicine, Odense University Hospital, Active, not recruiting
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

No publications provided

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
Study First Received: November 3, 2011
Last Updated: November 7, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: National Board of Health

Keywords provided by Odense University Hospital:
Venous thromboembolic disease
Deep veinous thrombosis
Pulmonary embolism

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

ClinicalTrials.gov processed this record on October 22, 2014