New imaging method aims to spot dangerous clots
NCT ID NCT04022915
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a special PET scan tracer to see if it can find fresh blood clots in people with pulmonary embolism (PE) or deep vein thrombosis (DVT). Six adults with confirmed clots received the tracer within 72 hours of diagnosis. The goal was to compare the PET images with standard CT scans and ultrasounds to improve clot detection.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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May 2019
- Finished
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Aug 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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