Trial Outcomes & Findings for Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography (NCT NCT01683825)
NCT ID: NCT01683825
Last Updated: 2025-11-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
1 day
Results posted on
2025-11-20
Participant Flow
Participant milestones
| Measure |
F-18 Florbetapir PET-Cardiac Amyloidosis Subjects
Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
F-18 Florbetapir PET-Healthy Controls
Individuals without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
F-18 Florbetapir PET Cardiac Amyloidosis Reproducibility Arm
Individuals with documented cardiac amyloidosis will undergo two F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET) scans within 30 days.
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
7
|
|
Overall Study
COMPLETED
|
10
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography
Baseline characteristics by cohort
| Measure |
F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis
n=10 Participants
Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
F-18 Florbetapir PET- Controls Without Cardiac Amyloidosis
n=6 Participants
Individuals without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
F-18 Florbetapir PET- Subjects With Cardiac Amyloidosis Reproducibility Arm
n=7 Participants
Individuals with documented cardiac amyloidosis will undergo two F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET) scans.
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.8 years
STANDARD_DEVIATION 13.9
|
57.5 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
68.1 years
STANDARD_DEVIATION 5.8 • n=8 Participants
|
64.8 years
STANDARD_DEVIATION 12.2 • n=19 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=8 Participants
|
8 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=8 Participants
|
15 Participants
n=19 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=19 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=8 Participants
|
19 Participants
n=19 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
10 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=8 Participants
|
23 Participants
n=19 Participants
|
|
Type of amyloidosis
Light chain cardiac amyloidosis
|
5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=8 Participants
|
12 Participants
n=19 Participants
|
|
Type of amyloidosis
Transthyretin cardiac amyloidosis
|
5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=19 Participants
|
|
Type of amyloidosis
Controls without cardiac amyloidosis
|
0 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: 10 cardiac amyloidosis subjects, 6 control subjects without cardiac amyloidosis, and 7 subjects with cardiac amyloidosis were included.
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.
Outcome measures
| Measure |
F-18 Florbetapir PET-Cardiac Amyloidosis Subjects
n=10 Participants
Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
F-18 Florbetapir PET- Controls Without Cardiac Amyloidosis
n=6 Participants
Control subjects without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
F-18 Florbetapir PET-Cardiac Amyloidosis Subjects in Reproducibility Arm
n=7 Participants
Individuals with documented cardiac amyloidosis will undergo two F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
|---|---|---|---|
|
Mean Left Ventricular Myocardial F-18 Florbetapir SUVmean
|
3.2 ratio
Standard Deviation 1.6
|
1.7 ratio
Standard Deviation 0.9
|
5.0 ratio
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Repeat scan was performed a median of 7 days after baseline study (range 1-46 days)Population: Subjects with cardiac amyloidosis who underwent two F-18 florbetapir PET/CT scans.
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%.
Outcome measures
| Measure |
F-18 Florbetapir PET-Cardiac Amyloidosis Subjects
n=7 Participants
Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
F-18 Florbetapir PET- Controls Without Cardiac Amyloidosis
Control subjects without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
F-18 Florbetapir PET-Cardiac Amyloidosis Subjects in Reproducibility Arm
Individuals with documented cardiac amyloidosis will undergo two F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
F-18 florbetapir PET: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
|
|---|---|---|---|
|
Percent Change in Global Left Ventricular F-18 Florbetapir SUVmean From Scan 1 to Scan 2
|
5.65 % change in SUVmean and SD
Standard Deviation 19.9
|
—
|
—
|
Adverse Events
F-18 Florbetapir PET-Cardiac Amyloidosis Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
F-18 Florbetapir PET-Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
F-18 Florbetapir PET-Cardiac Amyloidosis Subjects Reproducibility Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sharmila Dorbala, Director Nuclear Cardiology
Brigham and Women's Hospital
Phone: 617-732-6290
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place