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ENROLLING BY INVITATION
NCT07771621
PHASE1

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

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: [18F]-Fluselenamyl PET Imaging for Cardiac Amyloidosis (FSA-CA)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-01-14

Completion Date

2030-12

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

DRUG

[18F]Fluselenamyl (FSA)

Participants will receive a single intravenous administration of the investigational PET radiotracer\[18F\]Fluselenamyl (FSA) followed by positron emission tomography (PET) imaging to evaluate myocardial amyloid deposition and assess the imaging characteristics of the radiotracer in cardiac amyloidosis. The study will also collect safety data, including monitoring for adverse events and clinical assessments

Locations (1)

Washington University in St. Louis

St Louis, Missouri, United States