NCT07771621Enrolling by invitationPhase 1
PET Imaging With [18F]Fluselenamyl in People With Cardiac Amyloidosis
[18F]-Fluselenamyl PET Imaging for Cardiac Amyloidosis (FSA-CA)
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 30 Jul 2026
- Start date
- 14 Jan 2026
- Primary completion date
- Dec 2029
- Lead sponsor
- Washington University School of Medicine
- Diseases
- Amyloidosis
- NCT number
- NCT07771621
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 50
- From 14 Jan 2026 to the primary completion date, Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University in St. Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.