Healthy VolunteerEarly Phase 1NCT07801976
Positron Emission Tomography (PET) Imaging of Reactive Oxygen and Nitrogen Species: Human Observation of Retention and Safety of [18F]-Fluoroedaravone
A Early Phase 1 study testing [18F]Fluoroedaravone ([18F]FEDV) and PET/CT Imaging in people with Healthy Volunteer, run by St. Jude Children's Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- [18F]Fluoroedaravone ([18F]FEDV) and PET/CT Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Nov 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
Oxidative stress occurs when the body produces more reactive oxygen and nitrogen species than it can remove. Oxidative stress has been linked to inflammation, tissue injury, and a variety of diseases. Researchers believe it may also contribute to long-term health problems experienced by some survivors of childhood cancer, including cognitive difficulties. However, there are currently no clinically available imaging methods that directly measure oxidative stress in living people.
This first-in-human study will evaluate a new investigational PET imaging tracer called[18F]fluoroedaravone ([18F]FEDV). The tracer is designed to detect and measure oxidative stress in the body using positron emission tomography (PET) imaging. Before this tracer can be studied in patient populations, it is important to determine its safety, biodistribution, and radiation dosimetry in healthy adults.
Approximately 10 healthy adult volunteers will be enrolled. Each participant will receive a single intravenous injection of [18F]FEDV followed by a series of PET/CT imaging scans over approximately 3 hours. Researchers will evaluate how the tracer distributes throughout the body, how long it remains in different organs and tissues, and how it is cleared from the body. These data will be used to estimate radiation exposure and identify organs that receive the highest tracer uptake.
Safety will be assessed through monitoring of adverse events, vital signs, electrocardiograms (ECGs), symptom questionnaires, and laboratory testing. Blood and urine samples will be collected before and after tracer administration to assess safety and to better understand the metabolism and elimination of the tracer. Participants will return for a follow-up visit 48 to 96 hours after tracer administration for additional safety evaluations.
The main purpose of this study is to determine whether[18F]FEDV is safe to use in healthy adults and to learn how it moves through and leaves the body after injection. Information from this study will help researchers use this imaging tracer in future studies of oxidative stress in cancer survivors and other health conditions. The long-term goal is to develop a PET imaging tool that can help doctors and researchers better measure oxidative stress in the body.
- Conditions
- Healthy Volunteer
- Being tested
- [18F]Fluoroedaravone ([18F]FEDV), PET/CT Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]Fluoroedaravone ([18F]FEDV)Drug
Investigational fluorine-18 labeled edaravone PET radiotracer administered by intravenous injection
PET/CT ImagingProcedure or surgery
Whole-body PET/CT imaging performed following administration of [18F]FEDV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [18F]Fluoroedaravone ([18F]FEDV); Procedure: PET/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, with an average of 3 months post-PET/CT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiel Neumann, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801976
- Sponsor's protocol ID
- IRONHORSE
- Status last verified
- Nov 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography (PET) Imaging of Reactive Oxygen and Nitrogen Species: Human Observation of Retention and Safety of [18F]-Fluoroedaravone
- ClinicalTrials.gov ID
- NCT07801976
- Acronym / sponsor ID
- IRONHORSE
- Conditions
- Healthy Volunteer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Oxidative stress occurs when the body produces more reactive oxygen and nitrogen species than it can remove. Oxidative stress has been linked to inflammation, tissue injury, and a variety of diseases. Researchers believe it may also contribute to long-term health problems experienced by some survivors of childhood cancer, including cognitive difficulties. However, there are currently no clinically available imaging methods that directly measure oxidative stress in living people.
This first-in-human study will evaluate a new investigational PET imaging tracer called[18F]fluoroedaravone ([18F]FEDV). The tracer is designed to detect and measure oxidative stress in the body using positron emission tomography (PET) imaging. Before this tracer can be studied in patient populations, it is important to determine its safety, biodistribution, and radiation dosimetry in healthy adults.
Approximately 10 healthy adult volunteers will be enrolled. Each participant will receive a single intravenous injection of [18F]FEDV followed by a series of PET/CT imaging scans over approximately 3 hours. Researchers will evaluate how the tracer distributes throughout the body, how long it remains in different organs and tissues, and how it is cleared from the body. These data will be used to estimate radiation exposure and identify organs that receive the highest tracer uptake.
Safety will be assessed through monitoring of adverse events, vital signs, electrocardiograms (ECGs), symptom questionnaires, and laboratory testing. Blood and urine samples will be collected before and after tracer administration to assess safety and to better understand the metabolism and elimination of the tracer. Participants will return for a follow-up visit 48 to 96 hours after tracer administration for additional safety evaluations.
The main purpose of this study is to determine whether[18F]FEDV is safe to use in healthy adults and to learn how it moves through and leaves the body after injection. Information from this study will help researchers use this imaging tracer in future studies of oxidative stress in cancer survivors and other health conditions. The long-term goal is to develop a PET imaging tool that can help doctors and researchers better measure oxidative stress in the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment - [18F]Fluoroedaravone PET Imaging | Experimental | Drug: [18F]Fluoroedaravone ([18F]FEDV), Procedure: PET/CT ImagingHealthy 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]Fluoroedaravone ([18F]FEDV)Investigational fluorine-18 labeled edaravone PET radiotracer administered by intravenous injection | Drug | Treatment - [18F]Fluoroedaravone PET Imaging |
| PET/CT ImagingWhole-body PET/CT imaging performed following administration of [18F]FEDV | Procedure or surgery | Treatment - [18F]Fluoroedaravone PET Imaging |
Primary outcome
Evaluate safety of [18F]fluoroedaravone administration in up to 10 human subjects.
Time frame: Baseline at study entry and within 4 days following PET/CT.
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.
Evaluate the biodistribution of [18F]fluoroedaravone in up to 10 human subjects.
Time frame: Through study completion, with an average of 3 months post-PET/CT.
Calculate the absorbed dose of [18F]fluoroedaravone in normal organs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kiel Neumann, PhD principal investigator
St. Jude Children's Research Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]Fluoroedaravone ([18F]FEDV) and PET/CT Imaging in people with Healthy Volunteer, run by St. Jude Children's Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiel Neumann, PhD (866-278-5833, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety of [18F]fluoroedaravone administration in up to 10 human subjects. (time frame: Baseline at study entry and within 4 days following PET/CT.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.