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PET Imaging of Thrombosis with [64Cu]FBP8

This study is testing a new way to find blood clots (thrombosis) in the body using a special imaging technique called PET/MR (Positron Emission Tomography/Magnetic Resonance). You might be able to join if you are between 18 and 85 years old and have conditions like Atrial Fibrillation (an irregular heartbeat), COVID-19, or cancer. The study uses an injected drug called [64Cu]FBP8 (Copper-64 radiopeptide) along with the PET/MR scan to see if it can accurately detect clots. For people with Atrial Fibrillation, you'll need a recent TEE (transesophageal echocardiogram) to check for clots in your heart. The main goal is to see if this new method can safely and accurately find clots, potentially offering a less invasive option than current tests. The study is currently unclear on its recruitment status and plans to enroll 165 participants.

Study design
This interventional study plans to enroll 165 participants aged 18-85. It is evaluating the use of [64Cu]FBP8 with PET/MR imaging to detect thrombosis.
What's involved
You would receive an injection of [64Cu]FBP8, undergo a whole-body PET/MR scan, have blood collected before, during, and after imaging, and receive an electrocardiogram (ECG) before and after the injection.
Compensation
Not stated in the trial record.
Follow-up
Blood count will be measured at 36 hours, and Target to Background Ratio will be measured at 4 hours after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03830320

Positron Emission Tomography (PET) Imaging of Thrombosis

Recruiting
PHASE1Ages 18–85InterventionalDiagnostic
Massachusetts General Hospital
~165 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:[64Cu]FBP8PET/MRBlood CollectionElectrocardiogram

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete blood count
Measured over 36 hours
+3 more outcomes measured

Conditions

Atrial Fibrillation
COVID-19
Cancer
Thrombosis

Explore related trials

Atrial FibrillationCOVID-19 InfectionMalignant NeoplasmThrombosis

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Ciprian Catana, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

David E Sosnovik, MD
[email protected]
617-724-3407
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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);

Exclusion

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

What this trial measures

  • Complete blood count36 hours

    To model pharmacokinetics of \[64Cu\]FBP8 metabolism in healthy volunteers.

  • Target to Background Ratio LAA4 hours

    To determine the signal threshold of \[64Cu\]FBP8 that produces the highest accuracy of \[64Cu\]FBP8 -PET to detect left atrial thrombosis in patients with atrial fibrillation.

  • Target to Background Ratio4 hours

    To determine the signal threshold of \[64Cu\]FBP8 that produces the highest accuracy of \[64Cu\]FBP8 -PET to detect thrombosis in patients with known thrombus or suspicion of thrombus.

  • Time activity curve48 hours

    To evaluate human dosimetry and radiation burden in healthy volunteers.