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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT07110519
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • [18F]-fluoromannitol — DRUG
    \[18F\]-fluoromannitol is an investigational, novel radiotracer for use with PET scan imaging to help detect disease or infection.

Study Details

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.

Key Dates

Start date
Sep 17, 2025
Status verified
Apr 2026
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Participants
    Healthy adult volunteers who meet the eligibility criteria of the study. The study will evaluate the safety of \[18F\]-fluoromannitol as a tracer in healthy adult humans. Information will also be collected on the movement of the tracer in the body which may assist with diagnosing infections.

Primary Outcome Measure

Evaluate safety of [18F]fluoromannitol administration in up to 10 human subjects. [ Time Frame: Baseline at study entry and within 4 days following PET/CT. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Kiel Neumann, PhD
[email protected]
888-226-4343
Kiel Neumann, Phd (PRINCIPAL_INVESTIGATOR)

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By research site
St. Jude Children's Research Hospital· Memphis, TN

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