Venous Thromboembolic DiseasePETVETNCT01466426
The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders (The PETVET Study)
An observational study of Venous Thromboembolic Disease, run by Odense University Hospital at 3 sites in Denmark.
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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Venous Thromboembolic Disease
- How many people
- 40 participants
- Where
- 3 sitesDenmark
- Study dates
- Nov 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Positive or negative diagnosis of VTE (DVT/PE)
- Age ≥ 50 years
- Informed consent obtained
- Symptoms < 1 week
Who cannot join
- Pregnant or lactating women
- Foreign language patients with a need for an interpreter
- Previous DVT or PE
- Known malignancy
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Dept. of Acute Medicine, Odense University Hospital
Odense, dk-5000
Dept. of Nuclear Medicine, Odense University Hospital
Odense, dk-5000
Dept. of Respiratory Medicine, Odense University Hospital,
Odense, dk-5000
About this study
Official title: The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders
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.
Read the 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
- Keywords
- Venous thromboembolic disease, Deep veinous thrombosis, Pulmonary embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DVT confirmed | Not described | |
| DVT ruled out | Not described | |
| PE confirmed | Not described | |
| PE ruled out | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proof-of-concept
Simple assessment of scans - positive or negative in the relevant patient categories
Measured: During diagnostic workup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolic DiseaseStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Søren Hess, MD, Odense University Hospital
- Investigators
- Soeren Hess, MD, Study chair, Odense University HospitalPoul Henning Madsen, MD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466426
- Sponsor's protocol ID
- NMA projekt K 59 PETVET
- Acronym
- PETVET
- Status last verified
- Oct 2014
- First submitted
- 3 Nov 2011
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of FDG-PET/CT Imaging in the Management of Patients With Thromboembolic Disorders
- ClinicalTrials.gov ID
- NCT01466426
- Acronym / sponsor ID
- PETVET / NMA projekt K 59 PETVET
- Conditions
- Venous Thromboembolic Disease
- Keywords
- Venous thromboembolic disease, Deep veinous thrombosis, Pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DVT confirmed | – | – |
| DVT ruled out | – | – |
| PE confirmed | – | – |
| PE ruled out | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Positive or negative diagnosis of VTE (DVT/PE)
- Age ≥ 50 years
- Informed consent obtained
- Symptoms < 1 week
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Foreign language patients with a need for an interpreter
- Previous DVT or PE
- Known malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proof-of-concept
Time frame: During diagnostic workup
Simple assessment of scans - positive or negative in the relevant patient categories
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soeren Hess, MD study chair
Odense University Hospital
Poul Henning Madsen, MD study chair
Odense University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolic Disease, run by Odense University Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proof-of-concept (time frame: During diagnostic workup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.