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RECRUITING
NCT07560306
PHASE3

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

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-05-01

Completion Date

2027-03-30

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

DRUG

[64Cu]FBP8 PET/MR

Simultaneous cardiac PET/MR images will be obtained following injection of \[64Cu\]FBP8.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States