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NOT YET RECRUITING
NCT07801976
EARLY_PHASE1

Positron Emission Tomography (PET) Imaging of Reactive Oxygen and Nitrogen Species: Human Observation of Retention and Safety of [18F]-Fluoroedaravone

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

Summary

This first-in-human research study will test the safety of a new PET imaging tracer called\[18F\]fluoroedaravone (\[18F\]FEDV) in healthy adults. Participants will receive one injection of the tracer and undergo several PET/CT scans over about 3 hours. Researchers will collect blood and urine samples, check vital signs and heart activity (ECGs), and ask participants about any symptoms to learn how the tracer moves through and leaves the body and to monitor for side effects. Information from this study will help researchers develop this imaging tracer for future studies of oxidative stress, a process linked to inflammation and long-term health problems in cancer survivors and other diseases. Primary Objective(s): • Generate safety data and calculate biodistribution and organ dosimetry in healthy adult volunteers following \[18F\]fluoroedaravone intravenous administration.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2026-10

Completion Date

2028-11

Last Updated

2026-09-03

Healthy Volunteers

Yes

Interventions

DRUG

[18F]Fluoroedaravone ([18F]FEDV)

Investigational fluorine-18 labeled edaravone PET radiotracer administered by intravenous injection

PROCEDURE

PET/CT Imaging

Whole-body PET/CT imaging performed following administration of \[18F\]FEDV