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.
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.
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.
Single group
[18F]Fluoroedaravone ([18F]FEDV)
DrugInvestigational fluorine-18 labeled edaravone PET radiotracer administered by intravenous injection
PET/CT Imaging
Procedure/SurgeryWhole-body PET/CT imaging performed following administration of \[18F\]FEDV
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.
Evaluate the biodistribution of [18F]fluoroedaravone in up to 10 human subjects.
Calculate the absorbed dose of \[18F\]fluoroedaravone in normal organs.
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