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

St. Jude Children's Research Hospital

Status and phase: Enrolling; Early Phase 1

Conditions: Healthy

Treatments: Drug: [18F]-fluoromannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT07110519

PAKMANN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Participants

Experimental group

Description:

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.

Treatment:

Drug: [18F]-fluoromannitol