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NCT07771621 · ClinicalTrials.gov record · last posted 2026-08-18

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

Study acronym: FSA-CA
StatusEnrolling by Invitation
PhasePhase 1
Started2026-01-14
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from the ClinicalTrials.gov record
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.
Trial Details
NCT Number NCT07771621
Lead Sponsor Washington University School of Medicine
Conditions Cardiac Amyloidosis
Enrollment 50 participants
Start Date 2026-01-14
Primary Completion 2029-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-18