NCT05619302 · ClinicalTrials.gov record · last posted 2026-07-06
Molecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis
StatusActive, Not Recruiting
PhasePhase 3
Started2023-01-03
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from the ClinicalTrials.gov record
The primary aim of our pilot study is to determine whether fibrosis in the heart can be measured with \[68Ga\]CBP8, a positron emission tomography (PET) probe, using PET/magnetic resonance imaging (MRI) imaging, in 30 individuals with documented cardiac amyloidosis. The investigators will also enroll 15 individuals with recent myocardial infarction and 15 individuals with hypertrophic cardiomyopathy as positive controls for fibrosis, and the investigators will enroll 5 individuals without cardiovascular disease to undergo \[68Ga\]CBP8 PET/MRI imaging as a healthy control group.
The primary hypothesis of this study is that \[68Ga\]CBP8 will bind to interstitial collagen and quantify myocardial fibrosis in patients with cardiac amyloidosis. The investigators hypothesize that \[68Ga\]CBP8 uptake will be greater in patients with cardiac amyloidosis, myocardial fibrosis, and hypertrophic cardiomyopathy than in healthy controls. Secondly, the investigators also hypothesize that \[68Ga\]CBP8 activity more strongly correlates with standard MRI measures in patients with recent myocardial infarction and hypertrophic cardiomyopathy (where extracellular expansion is caused by myocardial fibrosis/collagen deposition) than in patients with cardiac amyloidosis (where myocardial fibrosis is combined with infiltration).
Amendment record
5 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 5 times since 2022-11-09; most recent amendment 2026-07-01. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
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2026-07-01
Status change Completed→Active, Not Recruitingv5
2026-03-27
Status change Recruiting→Completedv4
2023-07-25
Status change Not Yet Recruiting→Recruitingv1
| NCT Number |
NCT05619302 |
| Lead Sponsor |
Brigham and Women's Hospital
|
| Conditions |
Cardiac Amyloidosis |
| Enrollment |
18 participants |
| Start Date |
2023-01-03 |
| Primary Completion |
2026-12-31 (estimated) |
| Study Completion |
2026-12-31 (estimated) |
| Updated on ClinicalTrials.gov |
2026-07-06 |