Actively Recruiting
Positron Emission Tomography (PET) Contrast Agent Kinetics and Safety: [18F]-Fluoromannitol
Led by St. Jude Children's Research Hospital · Updated on 2026-04-24
10
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Positron Emission Tomography (PET) Contrast Agent Kinetics and Safety: [18F]-Fluoromannitol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18 to 75 years
- Female participants of childbearing age must not be lactating
- Signed informed consent according to institutional guidelines
You will not qualify if you...
- Current fever or symptoms of an active infection or undergoing treatment for infection
- Diagnosed or treated for bacterial infection within past 60 days
- Known lung, liver, kidney, gastrointestinal, bone/joint disease, immune suppression, or autoimmune disease likely with active inflammation
- Presence of prosthetic or indwelling devices currently or within past 60 days
- Pregnant or breastfeeding
- Use of drugs interacting with mannitol within 60 days of enrollment
- Any condition posing unacceptable risk or inability to tolerate PET scan procedures
- Inability or unwillingness to give informed consent
- Currently participating in another study subject to an IND
- Estimated glomerular filtration rate less than 45 ml/min/1.73m2
- Positive pregnancy test at study entry
- Clinically significant abnormal lab, vital signs, or ECG results at study entry
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
K
Kiel J Neumann, PhD
CONTACT
A
Amanda Green
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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