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

NCT ID: NCT07110519

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-17
• Study Completion Date: 2027-05-31

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.

Participants will be recruited primarily from St. Jude Children's Research Hospital employees and SJLIFE participants, and from the broader Memphis community if needed.

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

[18F]-fluoromannitol

Intervention Type: DRUG

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

Interventions

[18F]-fluoromannitol

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

Intervention Type: DRUG

Eligibility 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.
• 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.

At the time of the Final Eligibility Determination (Imaging Study Visit 1):

• Estimated glomerular filtration rate is < 45 ml/minute/1.73m2
• Positive pregnancy test (females only)
• One or more of the results from laboratory (hematology, chemistries, inflammatory markers), vital signs, or ECG specified in the schedule of evaluations is outside the normal institutional range AND is clinically significant in the opinion of the investigator.

Re-screening will not be allowed unless the Investigator considers the cause of the initial screen failure to be of an acute and/or completely reversible nature.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kiel Neumann, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kiel Neumann, PhD

Role: CONTACT

referralinfo@stjude.org

866-278-5833

Amanda Green

Role: CONTACT

referralinfo@stjude.org

866-278-5833

Facility Contacts

Kiel Neumann, PhD

Role: primary

referralinfo@stjude.org

866-278-5833

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

PAKMANN

Identifier Type: -

Identifier Source: org_study_id