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NCT05619302 · ClinicalTrials.gov registry record · Phase 3
Molecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis
A Phase 3 study of Cardiac Amyloidosis, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT05619302: Recruiting Phase 3 study of Cardiac Amyloidosis, sponsored by Brigham and Women's Hospital.
NCT05619302 is a Phase 3 study of Cardiac Amyloidosis that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 65 participants, below the 947-participant average among 8 other Cardiac Amyloidosis trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05619302, a Phase 3 study of Cardiac Amyloidosis, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
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).
Primary Outcome
Standardized uptake value (SUV) mean is defined as the mean \[68Ga\]CBP8 concentration measured within the left ventricular myocardium multiplied by the decay-corrected amount of injected \[68Ga\]CBP8 normalized to patient weight. We expect SUVmean will be greater in patients with cardiac amyloidosis and myocardial infarction compared with healthy control subjects.
Conditions Studied
Interventions
- DRUG [68Ga]CBP8 PET/MRI
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2023-01-03 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
What NCT05619302 shows while recruiting
NCT05619302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 947-participant average among 8 other Cardiac Amyloidosis trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Cardiac Amyloidosis appearing as the primary indexed condition, and to 1 intervention - of which [68Ga]CBP8 PET/MRI is the first listed.
NCT05619302 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05619302 about?
NCT05619302 is a clinical study titled "Molecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis". 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 enrol...
What is the current status of trial NCT05619302?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2023-01-03. Estimated completion is 2025-12-31.
What conditions does trial NCT05619302 study?
This clinical trial studies the following conditions: Cardiac Amyloidosis.
What interventions are being tested in trial NCT05619302?
The interventions under investigation include: [68Ga]CBP8 PET/MRI (DRUG).
Who is sponsoring clinical trial NCT05619302?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05619302 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05619302's enrollment target sits among peer trials
65 7th of 8 higher than 2 of 8 other Cardiac Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiac Amyloidosis 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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