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Investigating [18F]-Fluoromannitol for PET Scans

This study is looking at a new substance called [18F]-fluoromannitol, which is used with PET scans (a type of imaging that helps detect disease or infection). Researchers want to understand how safe [18F]-fluoromannitol is and how it moves through the body in healthy adults. This information could eventually help doctors detect infections in people with conditions like Sickle Cell Disease, cancer, or those with joint implants. The study aims to gather safety data from up to 10 healthy volunteers. We are currently recruiting participants for this study.

Study design
This is a Phase 0 study, meaning it's an early look at a new substance. It's a single-group study, meaning all participants will receive the same intervention.
What's involved
You would receive an intravenous (into a vein) injection of [18F]-fluoromannitol and have PET scans. Blood and urine samples will be collected, and your vital signs and symptoms will be monitored.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be checked within 4 days after the PET/CT scan. The study will track how [18F]-fluoromannitol moves through your body until the study ends, which is an average of 3 months after your PET/CT scan.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07110519

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

Active, Not Recruiting
EARLY_PHASE1Ages 18–75InterventionalDiagnostic
St. Jude Children's Research Hospital
~11 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:[18F]-fluoromannitol

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate safety of [18F]fluoromannitol administration in up to 10 human subjects.
Measured over Baseline at study entry and within 4 days following PET/CT.
+1 more outcome measured

Conditions

Healthy

Explore related trials

Healthy Volunteer

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Kiel J Neumann, PhD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
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.

What this trial measures

  • 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.