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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05619302
The ClinicalTrials.gov registry entry for NCT05619302 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 947-participant average among 8 other Cardiac Amyloidosis trials with a reported enrollment target (93% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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