Phase 4
N=23
Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography
Cardiac Amyloidosis
Bottom Line
View on ClinicalTrials.gov: NCT01683825 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Mean Left Ventricular Myocardial F-18 Florbetapir SUVmean — 3.2; 1.7; 5.0 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- F-18 florbetapir PET (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Left Ventricular Myocardial F-18 Florbetapir SUVmean |
3.2; 1.7; 5.0 | — |
| SECONDARY Percent Change in Global Left Ventricular F-18 Florbetapir SUVmean From Scan 1 to Scan 2 |
5.65 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01683825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.