Actively Recruiting
[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy
Led by Brigham and Women's Hospital · Updated on 2026-05-01
20
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written informed consent
- History of amyloid cardiomyopathy (transthyretin or light chain types)
- History of atrial fibrillation or atrial flutter
- Retrospective enrollment requires a transesophageal echocardiogram (TEE) to evaluate left atrial appendage within the past 14 days with stable anticoagulation
- Prospective enrollment requires TEE scheduled within the next 14 days
You will not qualify if you...
- Presence of electrical implants such as pacemaker, defibrillator, perfusion pump, or brain stimulator
- Pregnancy or breastfeeding (negative pregnancy test required for females with childbearing potential)
- Claustrophobia
- Radiation exposure exceeding 50 mSv in the past 12 months
- Inability to lie comfortably inside the PET/MR scanner
- Direct or indirect supervision by the principal investigator
- Body weight over 300 pounds (weight limit for MR table)
- Metallic or electric implants not compatible with PET/MR scanning
- Stroke, heart attack, or major cardiac surgery within the last 3 months
- History of left atrial appendage ligation, exclusion, or occlusion device
- History of fainting within the last 6 weeks
- Persistent heart rate over 120 bpm or under 50 bpm
- Daytime pauses in heartbeat longer than 3 seconds
- No prior transthoracic echocardiogram within the last 6 months
- Inability to provide written informed consent
- Deemed clinically unsuitable by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
V
Vicente Morales Oyarvide, MD, MPH
CONTACT
S
Sharmila Dorbala, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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