A Phase 3 interventional study of [64Cu]FBP8 PET/MR in Cardiac Amyloidosis, sponsored by Brigham and Women's Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Brigham and Women's Hospital · Phase 3, Interventional, and Diagnostic
The primary goal of this pilot study is to determine whether [64Cu]FBP8, a novel fibrin-binding positron emission tomography (PET) probe, can identify intracardiac thrombi when paired with simultaneous hybrid cardiac PET/MRI in twenty (20) individuals with transthyretin or light chain cardiac amyloidosis and atrial fibrillation (AF) or atrial flutter (AF).
The primary hypothesis of this study is that [64Cu]FBP8 PET/MRI can identify intracardiac thrombi in >90% of subjects with confirmed intracardiac thrombi based on transesophageal echocardiogram (TEE). In secondary analyses, the investigators will seek to determine associations between intracardiac thrombi and left atrial function and left ventricular amyloid burden.
[64Cu]FBP8 is a novel copper-64 labeled molecular imaging probe that selectively binds to fibrin, the main constituent of human thrombi. In animal models, [64Cu]FBP8 has been shown to effectively detect pulmonary emboli, deep venous thromboses, and intracardiac thrombi. In a first-in-human study, [64Cu]FBP8 paired with simultaneous cardiac positron emission tomography (PET) and magnetic resonance imaging (MRI) accurately detected intracardiac thrombi (specifically, left atrial appendage [LAA] thrombi) in patients with atrial fibrillation (AF) with an accuracy of >90% using transesophageal echocardiogram (TEE) as the reference standard. The investigators propose to study the value of [64Cu]FBP8 PET/MRI to detect intracardiac thrombi in patients with cardiac amyloidosis.
This pilot study is designed to assess the value of [64Cu]FBP8 PET/MRI to detect intracardiac thrombi in twenty (20) patients with cardiac amyloidosis and atrial fibrillation (AF) or atrial flutter (AFL) compared to TEE. The primary hypothesis is that [64Cu]FBP8 PET/MRI can identify intracardiac thrombi in >90% of subjects with confirmed intracardiac thrombi based on TEE. In secondary analyses, the investigators will seek to determine associations between intracardiac thrombi and left atrial function and left ventricular amyloid burden.
188 studies on the registry are indexed under Amyloid Neuropathies, Familial; 94 are open to participants now.
This study's planned enrollment of 20 is below the median of 54 across 90 interventional studies indexed under Amyloid Neuropathies, Familial.
Browse Amyloid Neuropathies, Familial studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals with documented cardiac amyloidosis and atrial fibrillation/atrial flutter will undergo \[64Cu\]FBP8 PET/MR.
Drug: [64Cu]FBP8 PET/MR
Simultaneous cardiac PET/MR images will be obtained following injection of \[64Cu\]FBP8.
Also known as: No other names
Intracardiac Thrombus
Presence or absence of intracardiac thrombus based on \[64Cu\]FBP8 PET/MR imaging, as determined by standardized uptake values (SUV), and transesophageal echocardiogram
Time frame: 1 day
Plan to share: No
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