This is a Phase 0 interventional, non-therapeutic study investigating the biodistribution and safety of \[18F\]-fluoromannitol as a radiotracer (a substance used to help detect disease or infection) in Positron Emission Tomography (PET) scans.
The primary objective of this study is to generate safety data in healthy adult human volunteers. In the future, this tracer may help to determine if a medical problem is infectious in people who have Sickle Cell Disease, cancer or other conditions that impact the immune system, or with people who have joint implants.
Primary Objective
\- Generate safety data, biodistribution and perform human organ dosimetry for \[18F\]- fluoromannitol as a novel PET tracer.
Participants will be recruited primarily from St. Jude Children's Research Hospital employees and SJLIFE participants, and from the broader Memphis community if needed.
Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
Informed consent signed by participant according to the guidelines of the institutional review board.
Participant currently has a fever or other symptoms concerning for an active infection or is currently undergoing treatment for an active infection.
Participant has been diagnosed and/or treated for a known or suspected bacterial infection within the past 60 days.
Participant has known disease of the lung, liver, kidneys, gastrointestinal tract, bones/joints, or known immune suppression or autoimmune disease that is likely to have active inflammation (examples to exclude: Crohn's disease, COPD; example to i include: well controlled asthma)
Participant has prosthetic or indwelling device(s) currently or has had one in the past 60 days.
Single group
[18F]-fluoromannitol
Drug\[18F\]-fluoromannitol is an investigational, novel radiotracer for use with PET scan imaging to help detect disease or infection.
Evaluate safety of [18F]fluoromannitol administration in up to 10 human subjects.
Safety will be assessed by the number and percentage of patients with adverse events following \[18F\]fluoromannitol 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]fluoromannitol in up to 10 human subjects.
Calculate the absorbed dose of \[18F\]fluoromannitol in normal organs.
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