[64Cu]FBP8 PET for Cardiac Amyloidosis

Overseen By Sharmila Dorbala, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Brigham and Women's Hospital

Disqualifiers: Pacemaker, Pregnancy, Claustrophobia, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with amyloid cardiomyopathy.

I have a history of atrial fibrillation or atrial flutter.

Ability to give written informed consent

Exclusion Criteria

I am being supervised by the study's main doctor or their team.

Body weight over the weight limit for the moving table (> 300 lbs for the MR table)

Lack of a prior transthoracic echocardiogram within the previous 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo [64Cu]FBP8 PET/MR imaging to detect intracardiac thrombi

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [64Cu]FBP8

How Is the Trial Designed?

Group I: [64Cu]FBP8 PET/MR Cardiac Amyloid and Atrial Fibrillation/Atrial Flutter Subjects Experimental Treatment 1 Intervention

Individuals with documented cardiac amyloidosis and atrial fibrillation/atrial flutter will undergo \[64Cu\]FBP8 PET/MR.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+