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

NCT07801976 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRONHORSE
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Evaluate safety of [18F]fluoroedaravone administration in up to 10 human subjects.

  Safety will be assessed by the number and percentage of patients with adverse events following \[18F\]fluoroedaravone administration. Adverse events will be categorized by the FDA's Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.

  Baseline at study entry and within 4 days following PET/CT.

• Evaluate the biodistribution of [18F]fluoroedaravone in up to 10 human subjects.

  Calculate the absorbed dose of \[18F\]fluoroedaravone in normal organs.

  Through study completion, with an average of 3 months post-PET/CT.

Study Arms (1)

Treatment - [18F]Fluoroedaravone PET Imaging

EXPERIMENTAL

Healthy adult volunteers receive a single intravenous injection of \[18F\]fluoroedaravone (\[18F\]FEDV), followed by serial whole-body PET/CT imaging evaluations. Participants also undergo blood collection, urine collection, vital sign monitoring, ECG assessments, symptom questionnaires, and a follow-up safety visit 48 to 96 hours after tracer administration.

Drug: [18F]Fluoroedaravone ([18F]FEDV); Procedure: PET/CT Imaging

Interventions

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

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

Treatment - [18F]Fluoroedaravone PET Imaging

PET/CT Imaging PROCEDURE

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

Treatment - [18F]Fluoroedaravone PET Imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers, 18-75 years of age.
• Informed consent signed by participant according to the guidelines of the institutional review board.
• Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.

You may not qualify if:

• Participant has been treated for cancer.
• Participant has experienced a stroke.
• Participant has history of seizures.
• Participant has been diagnosed with a neurodegenerative or neurodevelopmental disorder.
• Participant has been diagnosed with a psychiatric disorder such as bipolar or schizophrenia.
• Participant has been diagnosed or is suspected to have had a traumatic brain injury or concussion (TBI) within the last year.
• Participant has known disease of the lung, liver, kidneys, gastrointestinal tract, bones/joints, or known immune suppression or autoimmune disease likely to have active inflammation (examples to exclude: Crohn's disease, COPD, asthma)
• Participant has prosthetic or indwelling device(s), including IUD, currently, or has had one in the past 60 days.
• Participant has undergone any procedure of an internal organ.
• Participant is pregnant or breastfeeding.
• Estimated glomerular filtration rate \< 45 ml/minute/1.73m2
• Participants actively taking anti-inflammatory medication or have a condition requiring them to take anti-inflammatory medication (e.g. NSAIDs or steroids).
• Participant has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol, including being unable to tolerate the PET scan procedures.
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study Officials

• Kiel Neumann, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiel Neumann, PhD

CONTACT

866-278-5833; referralinfo@stjude.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available at the time of article publication.
• Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.