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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07560306
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cardiac Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Mar 30, 2027
Completion
Mar 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: [64Cu]FBP8 PET/MR Cardiac Amyloid and Atrial Fibrillation/Atrial Flutter Subjects
    Individuals with documented cardiac amyloidosis and atrial fibrillation/atrial flutter will undergo \[64Cu\]FBP8 PET/MR.

Primary Outcome Measure

Intracardiac Thrombus [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Vicente Morales Oyarvide, MD, MPH
[email protected]
617-233-5860
Sharmila Dorbala, MD, MPH
[email protected]
617-732-6290
Sharmila Dorbala, MD, MPH (PRINCIPAL_INVESTIGATOR)
Vicente Morales Oyarvide, MD, MPH (SUB_INVESTIGATOR)
Ciprian Catana, MD (SUB_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MA

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