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Can a new PET tracer reveal the Body's hidden stress?

NCT ID NCT07801976

Knowledge-focused Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This first-in-human study tests the safety of a new PET imaging tracer called [18F]fluoroedaravone in healthy adults. Participants receive one injection of the tracer and undergo several PET/CT scans over about three hours. Researchers collect blood and urine samples, check vital signs and heart activity, and ask about symptoms to learn how the tracer moves through and leaves the body. The goal is to gather safety data and measure radiation doses, which could help develop this tracer for future studies of oxidative stress, a process linked to inflammation and long-term health problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
An investigational imaging tracer called [18F]fluoroedaravone, given by injection, followed by PET/CT scans.
What this could lead to
If successful, this tracer could enable PET imaging of oxidative stress in the body, helping researchers study inflammation and long-term health issues in cancer survivors and other conditions.
What could go wrong
This is a very early, small study in healthy volunteers, so it will not show whether the tracer works for detecting disease. The main focus is safety, and side effects or unexpected tracer behavior could limit future use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteer

How to take part

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  1. The study's own enquiry address

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  2. The official record

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    Open the record ↗

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Contacts and locations

Study contacts

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