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

Venous Thromboembolic Disease Clinical Trial

— PETVET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466426
• Other study ID #: NMA projekt K 59 PETVET
• Status: Completed
• Phase: N/A
• First received: November 3, 2011
• Last updated: October 26, 2014
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: October 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolic Disease

Locations

Country	Name	City	State
Denmark	Dept. of Acute Medicine, Odense University Hospital	Odense
Denmark	Dept. of Nuclear Medicine, Odense University Hospital	Odense
Denmark	Dept. of Respiratory Medicine, Odense University Hospital,	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proof-of-concept	Simple assessment of scans - positive or negative in the relevant patient categories	During diagnostic workup	No