Imaging blood clots in pulmonary embolism and deep vein thrombosis
PET Fibrin Imaging of DVT and PE
PHASE1 · Massachusetts General Hospital · NCT04022915
This study is testing a new imaging method to see if it can help doctors better identify fresh blood clots in patients with pulmonary embolism and deep vein thrombosis.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04022915 on ClinicalTrials.gov |
What this trial studies
This study investigates a new PET imaging technique using a fibrin-specific probe, 64Cu-FBP8, to visualize fresh blood clots in patients diagnosed with pulmonary embolism (PE) and deep vein thrombosis (DVT). The goal is to improve the accuracy of diagnosing venous thromboembolism (VTE), which is a leading cause of mortality in the U.S. Current diagnostic methods often lead to misdiagnosis, especially in patients with renal failure or lung disease. By utilizing this novel imaging approach, the study aims to provide a comprehensive assessment of intravascular clots with a single test.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of pulmonary embolism within 72 hours.
Not a fit: Patients under 18 years of age or those who cannot undergo the imaging procedure due to physical limitations or excessive weight will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of blood clots, potentially reducing mortality rates associated with VTE.
How similar studies have performed: While this approach is novel, similar imaging techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older with a clinically significant pulmonary embolus (PE) confirmed by a filling defect in CT angiography (CTA), and * Subjects must receive the radiotracer injection within 72 hours of their diagnosis. Exclusion Criteria: * Subjects \< 18 years of age * Time of expected radiotracer injection \> 72 hours from the time of a positive venous duplex ultrasound or CT- angiogram * Women subjects of childbearing potential who are pregnant, seeking to become pregnant, or have a positive serum pregnancy (beta-HCG) test * Unable to lie flat for 45 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis, dyspnea), * Weight that exceeds the PET camera table limit (300 kg) * The subject will not be enrolled in the study if the radiation exposure for research studies during the prior 12 months, combined with the exposure from this study would exceed 50 mSv (millisievert). * Due to the radiation exposure from imaging studies, all women of childbearing potential will be required to have a negative serum pregnancy test performed prior to any imaging procedures on the same day (if not already done that day). Patients with a positive serum pregnancy test will be excluded. Breast feeding women will also be excluded. * A pre-existing condition or use of a medication including vasopressors and tPA (tissue Plasminogen Activator) that in the opinion of the investigator may place the subject at a substantially increased risk * Hemodynamic instability, including requiring escalating doses of vasopressor medication. * No groups designated as "special vulnerable populations" will be studied. * No exclusions will be made based on race, sex, or ethnic origin. * 64Cu-FBP8 (Copper-64 labeled fibrin binding probe 8) is cleared by the kidneys, patients with eGFR (estimated Glomerular Filtration Rate ) \< 30 will be excluded.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Tilo Winkler, PhD — Massachusetts General Hospital
- Study coordinator: Tilo Winkler, PhD
- Email: twinkler@mgh.harvard.edu
- Phone: 617-724-4083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Embolism, Deep Vein Thrombosis, Venous Thromboembolism