Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07110519

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

Led by St. Jude Children's Research Hospital · Updated on 2026-04-24

10

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy volunteers aged 18 to 75 years
  • Female participants of childbearing age must not be lactating
  • Signed informed consent according to institutional guidelines
Not Eligible

You will not qualify if you...

  • Current fever or symptoms of an active infection or undergoing treatment for infection
  • Diagnosed or treated for bacterial infection within past 60 days
  • Known lung, liver, kidney, gastrointestinal, bone/joint disease, immune suppression, or autoimmune disease likely with active inflammation
  • Presence of prosthetic or indwelling devices currently or within past 60 days
  • Pregnant or breastfeeding
  • Use of drugs interacting with mannitol within 60 days of enrollment
  • Any condition posing unacceptable risk or inability to tolerate PET scan procedures
  • Inability or unwillingness to give informed consent
  • Currently participating in another study subject to an IND
  • Estimated glomerular filtration rate less than 45 ml/min/1.73m2
  • Positive pregnancy test at study entry
  • Clinically significant abnormal lab, vital signs, or ECG results at study entry

AI-Screening

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Trial Site Locations

Total: 1 location

1

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

K

Kiel J Neumann, PhD

CONTACT

A

Amanda Green

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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