New scan could spot hidden blood clots without needles or surgery
NCT ID NCT03830320
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study is testing a new radioactive tracer called 64Cu-FBP8 that lights up blood clots on a special PET-MR scan. Researchers want to see if it can safely and accurately detect clots in people with atrial fibrillation, COVID-19, or cancer. The study involves 165 participants and aims to find a non-invasive alternative to current clot-detection methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 64Cu-FBP8 (a radioactive tracer)
- What this could lead to
- If successful, this could provide a safer, whole-body scan to detect dangerous blood clots without invasive procedures.
- What could go wrong
- This is a very early Phase 1 study focused on safety and imaging accuracy. The tracer may not prove reliable enough for routine use, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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About 165 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2016
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- 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 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
For Atrial Fibrillation Patient subjects: * History of atrial fibrillation or paroxysmal atrial fibrillation; * Retrospective enrollment: TEE to evaluate LAA within the last 14 days, provided the anticoagulation regimen the patient is on is not changed after the TEE. If a patient has a negative TEE and continues the same stable anti-coagulation regimen he/she is on, then it is extremely unlikely that a new thrombus will develop in the left atrial appendage within the next two weeks. Likewise, if a patient not taking any anti-coagulation has a thrombus in the left atrial appendage, then it is extremely unlikely that this thrombus will resolve spontaneously in the next 14 days if the patient continues not to take any anticoagulation. If the TEE leads to a change being made in the anticoagulation regimen (started/stopped/dose modified), then a time window of 72 hours from the TEE to PET imaging will be used. This scheme will ensure that the TEE can serve as an accurate gold standard; * Prospective enrollment: TEE to evaluate LAA scheduled in upcoming 14 days; For COVID-19 Patient subjects: * Positive test for SARS-CoV-2 RNA detected by RT-PCR collected from the upper or lower respiratory tract analyzed by a certified lab with an FDA approved assay within the last month; * Patient not requiring mechanical ventilation; For Cancer Patient subjects: • Patient is diagnosed with cancer; For Other Patient subjects: * Ultrasound- or CT-confirmed or high likelihood of thrombus (e.g., elevated D-dimer) * Has not received thrombolytics Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: * Subjects less than 18 years of age; * Electrical implants such as cardiac pacemaker or perfusion pump; * Pregnant or breastfeeding (a negative STAT quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate); * Claustrophobic reactions; * Subjects will be excluded if research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months); * Unable to lie comfortably on a bed inside the PET scanner; * Subjects under direct or indirect (i.e. same department as PIs) supervision of the principal investigator; * Body weight over the weight limit for the moving table (\> 300 lbs for the MRI table and \>441 lbs for the CT table); * Metallic or electric implants contraindicated for MR-PET scanning when applicable; * Does not have the ability to give written informed consent. * Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures); Additional exclusion criteria for Atrial Fibrillation Patient subjects: * Stroke within the last 3 months; * Myocardial infarction within the last 3 months; * Cardiac or major surgery within the last 3 months; * History of chest pain within the last 6 weeks unless followed by a subsequent stress test or coronary angiography; * History of syncope within the last 6 weeks; * Heart rate persistently \>120 bpm or persistently \< 50 bpm; * Presence of daytime pauses \> 3s
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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