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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
\[18F\]-fluoromannitol is an investigational, novel radiotracer for use with PET scan imaging to help detect disease or infection.
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
RECRUITINGEvaluate 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.
Time frame: Baseline at study entry and within 4 days following PET/CT.
Evaluate the biodistribution of [18F]fluoromannitol in up to 10 human subjects.
Calculate the absorbed dose of \[18F\]fluoromannitol in normal organs.
Time frame: Through study completion, with an average of 3 months post-PET/CT.
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