HealthyEarly Phase 1NCT07110519
Positron Emission Tomography (PET) Contrast Agent Kinetics and Safety: [18F]-Fluoromannitol
A Early Phase 1 study testing [18F]-fluoromannitol in people with Healthy, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [18F]-fluoromannitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2025to May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read more
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.
Read the 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
- Being tested
- [18F]-fluoromannitol
- Keywords
- Healthy, Adult, Age 18-75 years, Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-fluoromannitolDrug
[18F]-fluoromannitol is an investigational, novel radiotracer for use with PET scan imaging to help detect disease or infection.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | 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. Receives: Drug: [18F]-fluoromannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety of [18F]fluoromannitol administration in up to 10 human subjects.
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.
Measured: Baseline at study entry and within 4 days following PET/CT.
Evaluate the biodistribution of [18F]fluoromannitol in up to 10 human subjects.
Calculate the absorbed dose of [18F]fluoromannitol in normal organs.
Measured: Through study completion, with an average of 3 months post-PET/CT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start17 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiel J Neumann, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110519
- Sponsor's protocol ID
- PAKMANN
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography (PET) Contrast Agent Kinetics and Safety: [18F]-Fluoromannitol
- ClinicalTrials.gov ID
- NCT07110519
- Acronym / sponsor ID
- PAKMANN
- Conditions
- Healthy
- Keywords
- Healthy, Adult, Age 18-75 years, Volunteer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Drug: [18F]-fluoromannitolHealthy 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]-fluoromannitol[18F]-fluoromannitol is an investigational, novel radiotracer for use with PET scan imaging to help detect disease or infection. | Drug | Participants |
Primary outcome
Evaluate safety of [18F]fluoromannitol administration in up to 10 human subjects.
Time frame: 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.
Time frame: Through study completion, with an average of 3 months post-PET/CT.
Calculate the absorbed dose of [18F]fluoromannitol in normal organs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiel J Neumann, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]-fluoromannitol in people with Healthy, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety of [18F]fluoromannitol administration in up to 10 human subjects. (time frame: Baseline at study entry and within 4 days following PET/CT.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.