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[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
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: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 17, 2025Actual 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 
NCT07110519
Principal SponsorSt. Jude Children's Research Hospital
Study ContactKiel Neumann, PhDMore contacts
Last updated: December 11, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

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: * 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 known or suspected bacterial infection within the past 60 days. * Participant has known disease of the lung, liver, kidneys, gastrointestinal tract, bones/joints, or known immune suppression or autoimmune disease that is likely to have active inflammation (examples to exclude: Crohn's disease, COPD; example to i include: well controlled asthma) * Participant has prosthetic or indwelling device(s) currently or has had one in the past 60 days. * Participant is pregnant or breastfeeding. * Estimated glomerular filtration rate \< 45 ml/minute/1.73m2 * Use of drugs known to have interaction or be affected by mannitol within 60 days of enrollment. * Participant has any condition that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol, including being unable to tolerate the PET scan procedures. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. * Participant is currently participating in another study subject to an IND.

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.

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

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.

Calculate the absorbed dose of \[18F\]fluoromannitol in normal organs.

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 HospitalMemphis, United StatesSee the location
Recruiting
One Study Center