Clinical trial · Interventional
PET Imaging With [18F]Fluselenamyl in People With Cardiac Amyloidosis
[18F]-Fluselenamyl PET Imaging for Cardiac Amyloidosis (FSA-CA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiac Amyloidosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]Fluselenamyl (FSA) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cardiac Amyloidosis
- description
- Adults with known or suspected cardiac amyloidosis who will undergo PET imaging with the investigational amyloid-targeting radiotracer \[18F\]Fluselenamyl (FSA) to evaluate myocardial amyloid deposition and cardiac tracer uptake.
- interventionNames
- Drug: [18F]Fluselenamyl (FSA)
Primary outcomes (1)
- measure
- Cardiac Uptake of [18F]Fluselenamyl
- timeFrame
- Through study completion, an average of 2 years
- description
- Quantitative myocardial uptake of \[18F\]Fluselenamyl measured on PET images using standardized uptake values (SUVs) and/or target-to-background ratios to evaluate cardiac amyloid deposition.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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