A Phase 4 interventional study of F-18 florbetapir PET in Cardiac Amyloidosis, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Diagnostic
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.
F-18 florbetapir has been studied in multiple clinical trials to image beta-amyloid deposition in the brain of subjects with Alzheimers' disease. Florbetapir F-18 has been well tolerated in studies of more than 2000 human subjects. Biodistribution studies in humans revealed predominantly hepatobiliary excretion. The tracer clears rapidly from the blood pool in about 20 minutes. This radiotracer has been recently approved for clinical imaging of brain amyloid in subjects with suspected Alzheimers disease. The investigators propose to test this FDA approved radiotracer for an off label indication in a pilot study to evaluate its potential utility, if any, to image cardiac amyloidosis.
Amyloid related heart disease is associated with LV wall thickening due to infiltration; however, this myocardial wall thickening is not definitively distinguishable from left ventricular myocyte hypertrophy from increased afterload to the heart from hypertension or aortic stenosis. Typically myocardial or other tissue biopsy with typical echo features of amyloidosis is required for confirmation of amyloidosis. This pilot study is designed to understand whether cardiac amyloid burden can be measured using a specific radiotracer targeted against amyloid protein (F-18 Florbetapir). At this point it is unknown of F-18 Florbetapir will bind to either AL or TTR amyloid protein or to both of them or to neither of them. The investigators would like to study 15 patients with AL and 15 patients with TTR amyloidosis to understand these differences if any. The investigators also seek to understand if the signal to noise ratio of the circulating amyloid protein in the blood pool (AL amyloid disease) allows for good differentiation of myocardial amyloid uptake. 15 individuals without cardiac amyloidosis will also be enrolled as controls for this study.
The purpose of the proposed research study is to examine in detail, using quantitative PET, myocardial F-18 Florbetapir uptake in cardiac amyloidosis in order to better understand mechanisms of heart damage in this disease. A secondary aim of this study is to determine reproducibility of F-18 florbetapir imaging of the myocardium in a subset of patients with amyloidosis who return for a second F-18 florbetapir scan within 30 days.
122 studies on the registry are indexed under Amyloid Neuropathies, Familial; 71 are open to participants now.
This study's enrollment of 23 is below the median of 60 across 61 interventional studies indexed under Amyloid Neuropathies, Familial.
Browse Amyloid Neuropathies, Familial studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria for amyloid subjects:
Exclusion Criteria:
Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
Drug: F-18 florbetapir PET
Individuals without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
Drug: F-18 florbetapir PET
Some of the individuals with documented cardiac amyloidosis from arm 1 will undergo a second F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET) within 30 days to measure reproducibility
Drug: F-18 florbetapir PET
Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
Also known as: F-18 labeled Florbetapir (Trade Name: Amyvid)
Mean Left Ventricular Myocardial F-18 Florbetapir SUVmean
Standardized uptake value (SUV) mean is defined as the mean F-18 florbetapir activity concentration \[kBq/ml\] measured within the left ventricular myocardial region of interest multiplied by the decay-corrected amount of injected F-18 florbetapir \[kBq\] normalized to patient weight \[g\]. In this study we will measure mean left ventricular global myocardial F-18 Florbetapir SUVmean on static images between 4 minutes to 30 minutes post injection of F-18 florbetapir.
Time frame: 1 day
Percent Change in Global Left Ventricular F-18 Florbetapir SUVmean From Scan 1 to Scan 2
We evaluated change in F-18 florbetapir SUVmean from scan 1 to scan 2 as a percentage value \[(SUVmean1 minus SUVmean 2)/(SUVmean 1)\*100\]. In the 7 participants with cardiac amyloidosis who underwent two studies (median of 7 days apart), the percentage change in F-18 florbetapir SUVmean from scan 1 to scan 2 ranged from -38.5% to +20.8% with a median value of +2.24%.
Time frame: Repeat scan was performed a median of 7 days after baseline study (range 1-46 days)
| Milestone | F-18 Florbetapir PET-Cardiac Amyloidosis Subjects | F-18 Florbetapir PET-Healthy Controls | F-18 Florbetapir PET Cardiac Amyloidosis Reproducibility Arm |
|---|---|---|---|
| Started | 10 | 6 | 7 |
| Completed | 10 | 6 | 7 |
| Not completed | 0 | 0 | 0 |
Standardized uptake value (SUV) mean is defined as the mean F-18 florbetapir activity concentration \[kBq/ml\] measured within the left ventricular myocardial region of interest multiplied by the decay-corrected amount of injected F-18 florbetapir \[kBq\] normalized to patient weight \[g\]. In this study we will measure mean left ventricular global myocardial F-18 Florbetapir SUVmean on static images between 4 minutes to 30 minutes post injection of F-18 florbetapir.
| ratio | F-18 Florbetapir PET-Cardiac Amyloidosis Subjects | F-18 Florbetapir PET- Controls Without Cardiac Amyloidosis | F-18 Florbetapir PET-Cardiac Amyloidosis Subjects in Reproducibility Arm |
|---|---|---|---|
| Mean Left Ventricular Myocardial F-18 Florbetapir SUVmean | 3.2 ± 1.6 | 1.7 ± 0.9 | 5.0 ± 1.6 |
We evaluated change in F-18 florbetapir SUVmean from scan 1 to scan 2 as a percentage value \[(SUVmean1 minus SUVmean 2)/(SUVmean 1)\*100\]. In the 7 participants with cardiac amyloidosis who underwent two studies (median of 7 days apart), the percentage change in F-18 florbetapir SUVmean from scan 1 to scan 2 ranged from -38.5% to +20.8% with a median value of +2.24%.
| % change in SUVmean and SD | F-18 Florbetapir PET-Cardiac Amyloidosis Subjects in Reproducibility Arm |
|---|---|
| Percent Change in Global Left Ventricular F-18 Florbetapir SUVmean From Scan 1 to Scan 2 | 5.65 ± 19.9 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| F-18 Florbetapir PET-Cardiac Amyloidosis Subjects | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| F-18 Florbetapir PET-Healthy Controls | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| F-18 Florbetapir PET-Cardiac Amyloidosis Subjects Reproducibility Arm | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
This table includes baseline data for all 17 amyloidosis subjects including the 7 subjects who underwent a repeat F-18 florbetapir PET/CT scan for reproducibility as baseline characteristics did not change in the short time interval.
| Age, Continuous(years) | F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis | F-18 Florbetapir PET- Controls Without Cardiac Amyloidosis | F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis Reproducibility Arm | Total |
|---|---|---|---|---|
| Mean | 66.8 ± 13.9 | 57.5 ± 12.2 | 68.1 ± 5.8 | 64.8 ± 12.2 |
| Sex: Female, Male(Participants) | F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis | F-18 Florbetapir PET- Controls Without Cardiac Amyloidosis | F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis Reproducibility Arm | Total |
|---|---|---|---|---|
| Female | 4 | 1 | 3 | 8 |
| Male | 6 | 5 | 4 | 15 |
| Race (NIH/OMB)(Participants) | F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis | F-18 Florbetapir PET- Controls Without Cardiac Amyloidosis | F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis Reproducibility Arm | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 | 4 |
| White | 10 | 4 | 5 | 19 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis | F-18 Florbetapir PET- Controls Without Cardiac Amyloidosis | F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis Reproducibility Arm | Total |
|---|---|---|---|---|
| United States | 10 | 6 | 7 | 23 |
| Type of amyloidosis(Participants) | F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis | F-18 Florbetapir PET- Controls Without Cardiac Amyloidosis | F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis Reproducibility Arm | Total |
|---|---|---|---|---|
| Light chain cardiac amyloidosis | 5 | 0 | 7 | 12 |
| Transthyretin cardiac amyloidosis | 5 | 0 | 0 | 5 |
| Controls without cardiac amyloidosis | 0 | 6 | 0 | 6 |
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Amyloid Neuropathies, Familial→
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