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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Simultaneous cardiac PET/MR images will be obtained following injection of \[64Cu\]FBP8.
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGIntracardiac 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
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