Kinetics and safety of [18F]-fluoromannitol for PET scans

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

We will test whether the PET tracer [18F]-fluoromannitol is safe and how it moves through the body in healthy adults aged 18-75.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: St. Jude Children's Research Hospital (other)
• Drugs / interventions: radiation
• Locations: 1 site (Memphis, Tennessee)
• Trial ID: NCT07110519 on ClinicalTrials.gov

What this trial studies

This Phase 0, single-group prospective trial will administer intravenous [18F]-fluoromannitol to healthy adult volunteers under an FDA IND. Participants will undergo serial PET scans and provide blood and urine samples to map biodistribution and perform organ dosimetry. Vital signs and symptom checks will be collected to document immediate safety, and the protocol excludes people with recent infections, prosthetic devices, or certain inflammatory or immune-suppressing conditions. Recruitment is primarily from St. Jude employees and SJLIFE participants, with additional enrollment from the Memphis community as needed.

Who should consider this trial

Good fit: Healthy adults aged 18-75 who can give informed consent, are not lactating, and have no recent or active infections, prosthetic devices, or known inflammatory or immune-suppressing conditions.

Not a fit: People with active or recent infections, known inflammatory or immune-suppressing diseases, prosthetic or indwelling devices, pregnant or lactating individuals, and children would not be expected to benefit from this non-therapeutic Phase 0 study.

Why it matters

Potential benefit: If successful, this tracer could help doctors detect and localize infections in people with sickle cell disease, cancer, weakened immune systems, or joint implants.

How similar studies have performed: This is the first-in-human test of [18F]-fluoromannitol, although other PET tracers for infection imaging (such as FDG and labeled leukocytes) have been used successfully in humans.

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:

Initial Eligibility Exclusion Criteria (Entry to Screening Phase -

* 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.

Final Eligibility Exclusion Criteria (Entry to Study):

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

* Participant no longer meets one or more of the Inclusion Criteria
* Participant now fails one or more of the Initial Eligibility Exclusion Criteria
* 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.

Where this trial is running

Memphis, Tennessee

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (RECRUITING)

Study contacts

• Principal investigator: Kiel J Neumann, PhD — St. Jude Children's Research Hospital
• Study coordinator: Kiel J Neumann, PhD

Conditions: Healthy, Adult, Age 18-75 years, Volunteer