RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-09
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07110519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
  2. * Informed consent signed by participant according to the guidelines of the institutional review board.
  1. * Participant currently has a fever or other symptoms concerning for an active infection or is currently undergoing treatment for an active infection.
  2. * Participant has been diagnosed and/or treated for a known or suspected bacterial infection within the past 60 days.
  3. * 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)
  4. * Participant has prosthetic or indwelling device(s) currently or has had one in the past 60 days.
  5. * Participant is pregnant or breastfeeding.
  6. * Estimated glomerular filtration rate \< 45 ml/minute/1.73m2
  7. * Use of drugs known to have interaction or be affected by mannitol within 60 days of enrollment.
  8. * 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.
  9. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  10. * Participant is currently participating in another study subject to an IND.

Contacts and Locations

Study Contact

Kiel Neumann, PhD
CONTACT
866-278-5833
referralinfo@stjude.org
Amanda Green
CONTACT
866-278-5833
referralinfo@stjude.org

Principal Investigator

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

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-09
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • Healthy
  • Adult
  • Age 18-75 years
  • Volunteer

Additional Relevant MeSH Terms

  • Healthy