PET Imaging With [18F]Fluselenamyl in People With Cardiac Amyloidosis

Overview

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 positron emission tomography (PET) radiotracer that binds to amyloid fibrils and has shown promise for imaging amyloid deposition. This study is being conducted to evaluate the imaging characteristics of \[18F\]Fluselenamyl in individuals with cardiac amyloidosis and to determine its potential utility as a noninvasive imaging biomarker for cardiac amyloid burden. The investigation is based on prior development and human imaging experience with \[18F\]Fluselenamyl as an amyloid-targeting PET radiotracer. Participants with known or suspected cardiac amyloidosis will undergo PET imaging following intravenous administration of \[18F\]Fluselenamyl. Additional study procedures may include medical history review, physical examination, laboratory testing, electrocardiography, and collection of safety data before and after tracer administration. Imaging data will be analyzed to characterize tracer uptake within the myocardium and to assess the ability of \[18F\]Fluselenamyl PET to identify cardiac amyloid deposition. Safety assessments will include monitoring for adverse events, vital signs, clinical laboratory values, and other clinically relevant findings. The results of this study may support the development of \[18F\]Fluselenamyl as a novel PET imaging agent for the noninvasive detection and evaluation of cardiac amyloidosis and may provide information that could improve diagnosis, disease characterization, and future assessment of therapeutic response