NCT07110519 Positron Emission Tomography (PET) Contrast Agent Kinetics and Safety: [18F]-Fluoromannitol
| NCT ID | NCT07110519 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-09-17 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-09-17 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Kiel J Neumann, PhD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT07110519 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07110519 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07110519 currently recruiting?
Yes, NCT07110519 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT07110519 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT07110519 clinical trial?
NCT07110519 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Kiel J Neumann, PhD at St. Jude Children's Research Hospital. The trial plans to enroll 10 participants.