Venous Thromboembolism (VTE)THROMPETNCT06057844
Molecular Imaging of Active Venous Thrombus With Positron Emission Tomography (PET)
A study testing Additional blood sampling in people with Venous Thromboembolism (VTE), run by University Hospital, Brest at 1 site in France.
Trial summary
Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and/or pulmonary embolism (PE), is a major public health issue. VTE is the third most common acute cardiovascular pathology, after myocardial infarction and stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism (VTE)
- What is being tested?
- Additional blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2024to 28 Aug 2026
- Phase
- Interventional
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Major patient (≥18 years), voluntary blood donor, with no notable medical history altering coagulation (i.e. known thrombophilia, active cancer), no chronic pathology, no current treatment.
Who cannot join
- Minor patient (<18 years); known chronic pathology; long-term treatment including anti-platelet aggregation therapy or anticoagulant treatment, refusal to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Etablissement francais du sang
Brest, 29200
Jean-Baptiste THIBERT, 02.98.22.33.27
About this study
Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and/or pulmonary embolism (PE), is a major public health issue. VTE is the third most common acute cardiovascular pathology, after myocardial infarction and stroke.
Diagnostic accuracy is essential in the case of VTE, in order to select patients for whom anticoagulant treatment is necessary, and to avoid long-term treatment of patients who will derive no benefit from it.
Read more
The management of patients with suspected PE is based on diagnostic strategies that use either ventilation-perfusion planar lung scintigraphy or thoracic angioscanner imaging as the cornerstone. These 2 techniques correspond to what might be termed "negative" imaging, i.e. visualization of the vascular repercussions downstream of an obstruction, whatever its nature.
A research prospect in the field of VTE diagnosis is the direct marking of the various elements of the active venous thrombus, which could correspond to "positive" thrombus imaging.
Numerous studies have already investigated the role of molecular imaging in the diagnosis of VTE, especially in the diagnosis of DVT. However, these studies used conventional scintigraphy to evaluate these tracers, a technique lacking in sensitivity and with insufficient spatial resolution.
Nuclear medicine and molecular imaging have undergone a technological revolution since the early 2000s, with the development of positron emission tomography (PET). The technical advantages of PET over conventional scintigraphy include greater sensitivity and higher spatial resolution (4 mm for PET vs. 12 mm for conventional scintigraphy), which may have been the limiting factor in studies already carried out.
The aim of this project is to develop a new radiopharmaceutical for use in PET scans, a biomarker of active venous thrombus, with a view to improving the diagnosis of MVTE and hence patient management.
- Conditions
- Venous Thromboembolism (VTE)
- Being tested
- Additional blood sampling
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional blood samplingOther
Once you have been informed and have given your consent, 2 tubes of venous blood (citrated tubes of approximately 5 milliliters (ml) each) will be taken after the blood donation to enable in vitro thrombus formation. The entire sample will be used, and no surplus will be kept in the bank.
| Study group | Role | What they receive |
|---|---|---|
| Non applicable | Other | Not described Receives: Other: Additional blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the affinity and specificity of binding of a positron emitter-labeled anti-Dimer antibody (64Copper) to fresh blood thrombus in vitro.
Evaluation of the binding rate of a 64Copper-labeled D-dimer-specific monoclonal antibody (64Cu-Antibody) on fresh blood thrombus from healthy donors. The rate of binding will be assessed by measuring the radioactivity present on the thrombus (64Cu-Antibody bound to the thrombus) and the radioactivity present in the supernatant (64Cu-Antibody not bound to the thrombus).
Measured: Day +0
Secondary outcomes (1)
Optimize the antibody concentration required for the most effective tracer binding (64Cu-Antibody) to the thrombus.
Determination of the optimum 64Cu-Antibody concentration for the most effective thrombus labeling. Incorporate increasing amounts of 64Cu Antibody concentration, and measure the amount of binding to fresh thrombus and to the supernatant.
Measured: Day +0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start27 Feb 2024
- Primary completion28 Aug 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolism (VTE)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057844
- Sponsor's protocol ID
- 29BRC20.0202
- Acronym
- THROMPET
- Status last verified
- Jun 2026
- First submitted
- 19 Sep 2023
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided