Detection and Characterization of Thrombosis in Humans Using Fibrin-Targeted Positron Emission Tomography and Magnetic Resonance.
David Izquierdo-Garcia, Pauline Désogère, Anne L Philip...
https://pubmed.ncbi.nlm.nih.gov/34656469Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID07560306
[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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the ability of [64Cu]FBP8, a new fibrin-binding PET imaging probe, to detect intracardiac blood clots in people with transthyretin or light chain cardiac amyloidosis who also have atrial fibrillation or atrial flutter. This pilot study aims to see if [64Cu]FBP8 PET combined with cardiac MRI can identify clots in over 90% of patients confirmed to have intracardiac thrombi by transesophageal echocardiogram (TEE). The study also explores links between clots and heart function and amyloid burden. Participants will receive an injection of [64Cu]FBP8 followed by simultaneous cardiac PET/MR imaging to detect intracardiac thrombi. This imaging approach is compared against TEE results as a reference standard. The study involves twenty individuals with documented cardiac amyloidosis and atrial fibrillation or flutter undergoing this imaging procedure. During the trial, participants will have cardiac PET/MRI scans after tracer injection, with data collected to evaluate the presence of thrombi. The primary outcome is the detection of intracardiac thrombus within one day of imaging. Researchers will also assess heart function and amyloid levels. Safety and ability to complete the imaging procedure will be monitored. Participants' involvement includes consent, undergoing imaging, and review of recent TEE results over the study period.
CONDITIONS
Brief Title
[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent
- History of amyloid cardiomyopathy (ATTR-CM or AL-CM)
- History of atrial fibrillation or atrial flutter
- For retrospective enrollment: TEE to evaluate left atrial appendage within previous 14 days with stable anticoagulation
- For prospective enrollment: TEE to evaluate left atrial appendage thrombus scheduled within 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 of child-bearing potential)
- Claustrophobia
- Radiation exposure exceeding 50 mSv in prior 12 months
- Unable to lie comfortably inside PET/MR scanner
- Under supervision of the principal investigator or same department
- Body weight over 300 lbs for MR table
- Metallic or electric implants contraindicating PET/MR
- Stroke, myocardial infarction, or major cardiac surgery within last 3 months
- History of left atrial appendage ligation or occlusion device
- History of syncope within last 6 weeks
- Persistent heart rate above 120 bpm or below 50 bpm
- Daytime pauses longer than 3 seconds
- No prior transthoracic echocardiogram within previous 6 months
- Unable to give written informed consent
- Clinically unsuitable as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo simultaneous cardiac PET/MR imaging following injection of [64Cu]FBP8 to detect intracardiac thrombi.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
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Research Team
V
Vicente Morales Oyarvide, MD, MPH
S
Sharmila Dorbala, MD, MPH
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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Published Research Related To This Trial
Systemic embolism in amyloid transthyretin cardiomyopathy.
Silvia Vilches, Marianna Fontana, Esther Gonzalez-Lopez...
https://pubmed.ncbi.nlm.nih.gov/35650018Left Atrial Strain May Predict Thrombus Formation in Patients With Transthyretin Cardiac Amyloidosis.
Eoin Donnellan, Muzna Hussain, Nassir Marrouche...
https://pubmed.ncbi.nlm.nih.gov/37227355