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

Recruiting Phase 3 Interventional Study
Cardiac Amyloidosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
20 (estimated)
Sponsor
Brigham and Women's Hospital · Other
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About This Trial
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 i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Have the ability to give written informed consent; * History of amyloid cardiomyopathy (ATTR-CM or AL-CM); * History of AF or AFL; * Retrospective enrollment: TEE to evaluate LAA within the previous 14 days, provided the anticoagulation regimen the patient is on is not changed…
Contacts

Vicente Morales Oyarvide, MD, MPH

6172335860

vmorales-oyarvide@bwh.harvard.edu

CONTACT

Sharmila Dorbala, MD, MPH

617-732-6290

sdorbala@bwh.harvard.edu

CONTACT