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

StatusRecruiting
PhasePhase 3
Started2026-07-07
View on ClinicalTrials.gov ↗

Amendment history

2026-07-20
minor
Study Status, Contacts/Locations v1
Start dateestimated 2026-05-01→confirmed 2026-07-07
Study sitescontacts updated at 1 of 1 site
2026-04-24
minor
Original filing
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.
Trial Details
NCT Number NCT07560306
Lead Sponsor Brigham and Women's Hospital
Conditions Cardiac Amyloidosis
Enrollment 20 participants
Start Date 2026-07-07
Primary Completion 2027-03-30 (estimated)
Study Completion 2027-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-21