CompletedPhase 3

Molecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis

United States18 participantsStarted 2023-01-03

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria for AL-amyloid subjects: * Age \> 18 years * Willing and able to provide consent * AL-CA: Diagnosis of systemic light chain amyloidosis by standard criteria: Immunofixation of serum, serum free light chain (FLC) assay, a biopsy of fat pad/bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by mass spectroscopy as needed AND * Proof of cardiac involvement by AL amyloidosis * Abnormal cardiac biomarkers: abnormal high sensitivity TnT 5th generation levels (\> 15 ng/L) or abnormal age-appropriate NT-proBNP (abnormal values: \< 50 years: \> 450 pg/ml; 50-75 years: \> 900 pg/ml; \> 75 years: \> 1800 pg/ml) OR * Abnormal echocardiogram (wall thickness \> 12 mm in the absence of other causes of increased LV wall thickness) OR * Abnormal CMR (wall thickness \> 12 mm, extracellular volume \> 0.40 or typical CMR appearance of cardiac amyloidosis with difficulty nulling images and non-coronary distribution late gadolinium enhancement) OR * Positive endomyocardial biopsy Inclusion Criteria for ATTR-amyloid subjects: * Age \> 18 years * Willing and able to provide consent * ATTR-CA: Diagnosis of either wildtype or hereditary transthyretin cardiac amyloidosis by standard criteria: Endomyocardial biopsy followed by typing of the transthyretin amyloidosis using immunohistochemistry or immunogold assay with confirmation by mass spectroscopy as needed * Extracardiac biopsy with …

What they're measuring

Mean Standardized Uptake Value (SUVmean) of [68Ga]CBP8 uptake in the heart

Timeframe: 1 day

Extracellular volume from clinically performed simultaneous cardiac MRI

Timeframe: 1 day

Trial details

NCT IDNCT05619302

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31