The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders (The PETVET Study)
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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 |
| 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 |
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.
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| Contact: Soeren Hess, MD | +45 21 54 22 47 | hess@dadlnet.dk |
| Denmark | |
| 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 | |
| Dept. of Acute Medicine, Odense University Hospital | Recruiting |
| Odense, Denmark, dk-5000 | |
| Contact: Jens Jørgen Frifeldt, MD | |
| 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 Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis |
ClinicalTrials.gov processed this record on May 23, 2013