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

NCT07801976 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-09-03

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

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

Sponsors & Collaborators

Principal Investigators

  • Kiel Neumann, PhD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-11-30
Completion
2028-11-30
FDA Drug
Yes

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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 NCT07801976 on ClinicalTrials.gov