[18F]-Fluoromannitol for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new substance called [18F]-fluoromannitol, used in PET scans to track its distribution in the body and confirm its safety. Currently, the trial targets healthy adults, but it may eventually aid in detecting infections in individuals with conditions like Sickle Cell Disease or joint implants. The researchers seek healthy volunteers without recent infections or ongoing health issues affecting the lungs, liver, or immune system. As an Early Phase 1 trial, this research aims to understand how this new treatment works in people, offering volunteers the opportunity to be among the first to receive it.
Will I have to stop taking my current medications?
The trial requires that you stop using drugs known to interact with mannitol within 60 days before joining. If you're taking such medications, you may need to stop them to participate.
What prior data suggests that [18F]-fluoromannitol is safe as a PET tracer?
Research shows that [18F]-fluoromannitol is under study to determine its safety for use in PET scans. Previous studies have found that this imaging agent can quickly detect infections, allowing doctors to examine the body without surgery or other invasive procedures.
Since this trial is in its early stages, the primary goal is to assess the safety of [18F]-fluoromannitol in humans. Researchers aim to identify any side effects or issues in healthy volunteers. Although information is limited, studies suggest it has been well-tolerated so far.
As this is an early trial, the focus remains on safety, with researchers gathering data to ensure it does not cause harm. If [18F]-fluoromannitol resembles other agents, it might be safe, but further information is needed to confirm this.12345Why are researchers excited about this trial?
Unlike standard methods for diagnosing infections, which often rely on blood tests or imaging technologies like X-rays and MRI, [18F]-Fluoromannitol offers a new approach by acting as a tracer. This innovative compound is used in PET scans to track the movement of substances in the body, potentially providing more accurate and faster insights into infection sites. Researchers are excited about [18F]-Fluoromannitol because it could improve diagnostic precision and speed, helping doctors catch and treat infections more effectively.
What evidence suggests that [18F]-fluoromannitol is effective as a PET tracer?
A previous study found that a substance called [18F]-fluoromannitol shows promise as a tool for PET scans. This tool helps doctors view the body to detect infections. Early results suggest it moves safely through the body without causing harm. In this trial, healthy adult volunteers will receive [18F]-fluoromannitol to further evaluate its safety and track its movement. Researchers continue to gather information to confirm its safety and travel path. This research could eventually aid in diagnosing infections in individuals with certain health conditions, such as Sickle Cell Disease or cancer.13678
Who Is on the Research Team?
Kiel Neumann, PhD
Principal Investigator
St. Jude Children's Research Hospital
Are You a Good Fit for This Trial?
This trial is for healthy volunteers aged 18-75 who can give informed consent. Women of childbearing age must not be breastfeeding due to possible harm from radiation exposure.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Administration of intravenous [18F]-fluoromannitol as a radiotracer with subsequent PET scans
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- [18F]-Fluoromannitol
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor