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ACTIVE NOT RECRUITING
NCT05619302
PHASE3

Molecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis

Sponsor: Brigham and Women's Hospital

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2023-01-03

Completion Date

2026-12-31

Last Updated

2026-07-06

Healthy Volunteers

Yes

Interventions

DRUG

[68Ga]CBP8 PET/MRI

Simultaneous cardiac PET/MRI images will be obtained following injection of \[68Ga\]CBP8

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States