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

NCT07771621 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

  • Cardiac Amyloidosis

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-14
Primary Completion
2029-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07771621 on ClinicalTrials.gov