Washington University School of Medicine
This observational study will evaluate the imaging performance of the investigational positron emission tomography (PET) radiotracer\[18F\]Fluselenamyl (FSA) in individuals with cardiac amyloidosis. The study aims to determine whether \[18F\]Fluselenamyl PET imaging can detect and characterize amyloid deposits in the heart. Participants will undergo PET imaging following administration of \[18F\]Fluselenamyl, along with clinical assessments and other study procedures as needed. Imaging results will be used to assess tracer uptake in the heart and to evaluate the potential of \[18F\]Fluselenamyl as a noninvasive tool for detecting cardiac amyloidosis. The study will also collect safety information, including clinical assessments, laboratory testing, and monitoring for adverse events. This research may help establish \[18F\]Fluselenamyl as a novel imaging biomarker for cardiac amyloidosis.
Cardiac amyloidosis is a progressive disorder characterized by the deposition of misfolded amyloid proteins within the myocardium, leading to increased ventricular wall thickness, impaired cardiac function, heart failure, arrhythmias, and reduced survival. Early and accurate detection of cardiac amyloid deposits is important for diagnosis, treatment selection, and monitoring of disease progression. Current diagnostic approaches often require a combination of imaging studies, laboratory testing, and, in some cases, invasive tissue biopsy. \[18F\]Fluselenamyl (FSA) is an investigational positro…
Inclusion Criteria: * Male or Female, any race * Age ≥ 18 years * Confirmed CA, clinical suspicion for CA, or markers of potential CA (i.e. left ventricular hypertrophy and heart failure) * Willing and able to undergo \[F18\]-FSA PET scan, and cardiac MRI Exclusion Criteria: * Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent * Unwilling or unable to undergo PET scan tracer injections * Participants with chronic liver diseases not related to amyloidosis * Participant has any condition that, in the investigator's…
Participants will receive a single intravenous administration of the investigational PET radiotracer\[18F\]Fluselenamyl (FSA) followed by positron emission tomography (PET) imaging to evaluate myocardial amyloid deposition and assess the imaging characteristics of the radiotracer in cardiac amyloidosis. The study will also collect safety data, including monitoring for adverse events and clinical assessments
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