PET Imaging With [18F]Fluselenamyl in People With 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

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 opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with the collection/analysis of the data (e.g., participants with severe chronic back pain might not be able to lie still for the duration of the scanning procedures)
• Has hypersensitivity to [F-18]-Fluselenamyl or any of its excipients
• Contraindications to MRI (e.g. electronic medical devices that are not compatible with MRI, inability to lie still for extended periods that make it unsafe for the individual to participate)
• Contraindication to contrast (gadolinium) MRI given a glomerular filtration rate (GFR) of the kidney<30ml/min/1.7m2). In such case, only non-contrast MRI may be considered.
• Severe claustrophobia
• Currently pregnant or breast-feeding