Positron Emission Tomography (PET) Contrast Agent Kinetics and Safety: [18F]-Fluoromannitol

ConditionHealthy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSt. Jude Children's Research Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • [18F]-fluoromannitol

Treatment groups

10 Participants
are divided into 1 treatment group