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

NCT ID: NCT01466426

Last Updated: 2014-10-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-06-30

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.

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.

Conditions

Venous Thromboembolic Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

DVT confirmed

No interventions assigned to this group

DVT ruled out

No interventions assigned to this group

PE confirmed

No interventions assigned to this group

PE ruled out

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Søren Hess, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Soeren Hess, MD

Role: STUDY_CHAIR

Odense University Hospital

Poul Henning Madsen, MD

Role: STUDY_CHAIR

Odense University Hospital

Locations

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, , Denmark

Countries

Denmark

Other Identifiers

NMA projekt K 59 PETVET

Identifier Type: -

Identifier Source: org_study_id