Positron Emission Tomography (PET) Contrast Agent Kinetics and Safety: [18F]-Fluoromannitol
St. Jude Children's Research Hospital
Summary
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.
Description
This study is designed to evaluate the safety and movement throughout the body of 18F-FMtl in healthy adult volunteers. It will be conducted under an IND approved by the FDA. The IND is required as 18F-fMtl is not commercially available and has not been studied in humans. The design for this phase 0 study will be a single-group prospective trial. Primary intervention is the administration of intravenous \[18F\]-fluoromannitol as a radiotracer with subsequent PET scans. Associated interventions include collection of blood and urine samples, vital signs, and symptoms from participants.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Healthy volunteers, 18-75 years of age. * 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. Exclusion Criteria: Initial Eligibility Exclusion Criteria (Entry to Screening Phase - * 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…
Interventions
- Drug[18F]-fluoromannitol
\[18F\]-fluoromannitol is an investigational, novel radiotracer for use with PET scan imaging to help detect disease or infection.
Location
- St. Jude Children's Research HospitalMemphis, Tennessee