Heart scans with a new tracer in adults with cardiac amyloidosis
Tests a new scan tracer to find amyloid in the hearts of adults.
Plain-language title generated from the registry record
Registry title: PET Imaging With [18F]Fluselenamyl in People With Cardiac Amyloidosis
Key facts
- Where
- St Louis, United StatesSee the site
- Phase
- Phase 1
Where in United States
- Washington University in St. LouisSt Louis, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Washington University School of Medicine
- Trial code
- NCT07771621
- Record updated
- 18 August 2026
- Original description
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.Read full original descriptionShow less
[18F]-Fluselenamyl PET Imaging for Cardiac Amyloidosis (FSA-CA)
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.
Inclusion: 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: 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; 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; 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; 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); Severe claustrophobia; Currently pregnant or breast-feeding.