New imaging agent could help spot hidden infections
NCT ID NCT07110519
First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This early-phase study tests a new radioactive tracer called [18F]-fluoromannitol in 10 healthy adults. The tracer is designed to light up infections on PET scans. Researchers will check its safety and how it spreads through the body. If all goes well, it may later be tested in people with sickle cell disease, cancer, or joint implants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [18F]-fluoromannitol (a radioactive tracer for PET scans)
- What this could lead to
- If successful, this tracer could help doctors spot infections in people with sickle cell disease, cancer, or joint implants using PET scans.
- What could go wrong
- This is a very early (Phase 0) study with only 10 healthy people. It only checks safety and distribution, not whether it works for diagnosis. The tracer may not perform well in later studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
11 people
The number who actually took part.
- Started
-
Sep 2025
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
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