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

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Drug: [18F]-fluoromannitol

• Registration Number: NCT07110519
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Study First Posted: 2025-08-07
• Status Verified: 2025-09
• Study Start: 2025-09-17
• Last Update Submitted: 2025-09-17
• Last Update Posted: 2025-09-18
• Primary Completion: 2026-05
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	[18F]-fluoromannitol	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 Measures

Name	Time	Method
Evaluate safety of [18F]fluoromannitol administration in up to 10 human subjects.	Baseline at study entry and within 4 days following PET/CT.	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.
Evaluate the biodistribution of [18F]fluoromannitol in up to 10 human subjects.	Through study completion, with an average of 3 months post-PET/CT.	Calculate the absorbed dose of \[18F\]fluoromannitol in normal organs.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States