CompletedPhase 4

Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography

United States23 participantsStarted 2013-03-23

Plain-language summary

The primary aim of this pilot study is to determine whether amyloid deposits in the heart can be measured non-invasively by F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET) in 30 individuals with documented cardiac amyloidosis. We will also enroll 15 individuals without cardiac amyloidosis to undergo the F-18 florbetapir imaging as a control group. The primary hypothesis of this study is that a specific amyloid binding radiotracer will bind to the myocardial amyloid deposits and help quantify cardiac amyloid burden. A secondary aim of this study is to determine reproducibility of F-18 florbetapir imaging of the myocardium.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Inclusion criteria for amyloid subjects: * Age \> 18 years * Biopsy proven amyloidosis outside the heart with typical echocardiographic appearance of cardiac involvement, or a positive cardiac biopsy. * Diagnosis of AL amyloidosis by standard criteria (evidence of plasma cell dyscrasia with appropriate tissue staining for AL) OR * Diagnosis of TTR amyloidosis (no evidence of plasma call dyscrasia and positive TTR staining of amyloid in tissue biopsy) * Able and willing to provide informed consent to participate in the study procedures Exclusion Criteria: * Pregnancy * Serious non-cardiac medical illness which will preclude research study participation

What they're measuring

Mean Left Ventricular Myocardial F-18 Florbetapir SUVmean

Timeframe: 1 day

Trial details

NCT IDNCT01683825

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-04

Results submitted2022-01-22