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NCT01683825 · ClinicalTrials.gov registry record · Phase 4
Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT01683825: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT01683825 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01683825, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG F-18 florbetapir PET
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2013-03-23 |
| Est. Completion | 2018-10-10 |
| Phase | Phase 4 |
What the finished NCT01683825 record still lists
NCT01683825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which F-18 florbetapir PET is the first listed.
NCT01683825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01683825 about?
NCT01683825 is a clinical study titled "Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography". 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 cardi...
What is the current status of trial NCT01683825?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2013-03-23. Estimated completion is 2018-10-10.
What interventions are being tested in trial NCT01683825?
The interventions under investigation include: F-18 florbetapir PET (DRUG).
Who is sponsoring clinical trial NCT01683825?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01683825's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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