Healthy
Conditions
Keywords
Healthy, Adult, Age 18-75 years, Volunteer
Brief 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. 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.
Interventions
DRUG[18F]-fluoromannitol
\[18F\]-fluoromannitol is an investigational, novel radiotracer for use with PET scan imaging to help detect disease or infection.
Sponsors
St. Jude Children's Research Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate safety of [18F]fluoromannitol administration in up to 10 human subjects. | 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. | Through study completion, with an average of 3 months post-PET/CT. | Calculate the absorbed dose of \[18F\]fluoromannitol in normal organs. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKiel J Neumann, PhD
St. Jude Children's Research Hospital
Outcome results
None listed