[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy

This study is testing a new imaging method called [64Cu]FBP8 PET/MR to find blood clots inside the heart (intracardiac thrombi). This method uses a special tracer, [64Cu]FBP8, which sticks to blood clots, combined with PET and MRI scans. The study is for people with cardiac amyloidosis (a heart condition where abnormal proteins build up in the heart) and a history of atrial fibrillation (AF) or atrial flutter (AFL), which are types of irregular heartbeats. Researchers want to see if [64Cu]FBP8 PET/MR can find these clots in over 90% of participants who are known to have them based on another test called a TEE. The study aims to enroll 20 participants, but its current status is unclear.

Study design: This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 20 participants.
What's involved: You would receive an injection of [64Cu]FBP8 and then have simultaneous cardiac PET/MR images taken. You must have had a TEE within the previous 14 days.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint, intracardiac thrombus, is measured at 1 day.

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

[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy

Recruiting

PHASE3Ages 18+InterventionalDiagnostic

Brigham and Women's Hospital

~20 participants

Updated 2026-07-21 on ClinicalTrials.gov

What's tested:[64Cu]FBP8 PET/MR

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Intracardiac Thrombus

Measured over 1 day

Conditions

Cardiac Amyloidosis

NCT07560306

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Brigham and Women's Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Vicente Morales Oyarvide, MD, MPH

[email protected]

6172335860

Email the study team

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Eligibility criteria

Inclusion

Have the ability to give written informed consent;

History of amyloid cardiomyopathy (ATTR-CM or AL-CM);

History of AF or AFL;

Retrospective enrollment: TEE to evaluate LAA within the previous 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 anticoagulation regimen, then it is unlikely that a new thrombus will develop in the LAA within the next 14 days. Likewise, if a patient not taking any anticoagulation has a thrombus in the LAA, then it is unlikely that this thrombus will resolve spontaneously in the next 14 days if the patient remains off 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/MR imaging will be used. This scheme will ensure that the TEE can serve as an accurate gold standard;

Prospective: TEE to evaluate LAA thrombus scheduled in upcoming 14 days;

Exclusion

Electrical implants such as cardiac pacemaker/defibrillator, perfusion pump, direct brain stimulator;

Pregnancy or breastfeeding (a negative quantitative serum or urine hCG pregnancy test is required for females having child-bearing potential before the subject can participate);

Claustrophobia;

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/MR 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 MR table);

Metallic or electric implants contraindicated for PET/MR scanning;

Stroke, myocardial infarction, cardiac or major surgery within the last 3 months;

History of LAA ligation/exclusion or presence of a LAA occlusion device;

History of syncope within the last 6 weeks;

Heart rate persistently \>120 bpm or persistently \<50 bpm;

Daytime pauses \>3 seconds;

Lack of a prior transthoracic echocardiogram within the previous 6 months;

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);

What this trial measures

Intracardiac Thrombus1 day
Presence or absence of intracardiac thrombus based on \[64Cu\]FBP8 PET/MR imaging, as determined by standardized uptake values (SUV), and transesophageal echocardiogram

Trialytics