[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy
Start Date
7/7/2026
Completion Date
3/30/2027
Summary
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.
Detailed Description
\[64Cu\]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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
[64Cu]FBP8 PET/MR
Conditions
Locations
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States