Recruiting

[18F]-Fluoromannitol PET Contrast Agent in Healthy Volunteers

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What is being tested

[18F]-fluoromannitol

Drug
Who is being recruted

From 18 to 75 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Early Phase 1
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorSt. Jude Children's Research Hospital
Study ContactKiel Neumann, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 17, 2025

Actual date on which the first participant was enrolled.

This study focuses on understanding how a special imaging agent called 18F-Fluoromannitol (18F-FMtl) behaves in the body and checking its safety. This agent is used in a type of scan called a PET scan, which helps doctors see inside the body. The study involves healthy adult volunteers and is important because 18F-FMtl is not yet available for general use and hasn’t been tested in humans before. By evaluating how this agent moves through the body, researchers aim to gather important safety information, which could potentially lead to better diagnostic tools in the future. Participants in this study will receive 18F-FMtl through an intravenous injection, meaning it is administered directly into the bloodstream. Following this, PET scans will be conducted to track the agent’s movement and accumulation in the body. Additionally, researchers will collect blood and urine samples, monitor vital signs, and check for any symptoms to ensure safety. The study is carefully designed to evaluate these factors, providing a comprehensive understanding of the agent's behavior and safety profile.

Official TitlePositron Emission Tomography (PET) Contrast Agent Kinetics and Safety: [18F]-Fluoromannitol
Principal SponsorSt. Jude Children's Research Hospital
Study ContactKiel Neumann, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
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.

14 exclusion criteria prevent from participating
Estimated glomerular filtration rate is < 45 ml/minute/1.73m2

Positive pregnancy test (females only)

Participant currently has a fever or other symptoms concerning for an active infection or is currently undergoing treatment for an active infection.

Participant no longer meets one or more of the Inclusion Criteria

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

St. Jude Children's Research Hospital

Memphis, United StatesOpen St. Jude Children's Research Hospital in Google Maps
Recruiting
One Study Center