[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
Trial Overview
[18F]-fluoromannitol, a new PET scan radiotracer, is being tested for safety and how it spreads in the body. This Phase 0 study could lead to better detection of infections in patients with conditions like Sickle Cell Disease or cancer.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor
Citations
Study Details | NCT07110519 | Positron Emission ...
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 ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/35b828040fbb3046/nct07110519-pet-contrast-agent-18f-fluoromannitolPositron Emission Tomography (PET) Contrast Agent Kinetics ...
This study is designed to evaluate the safety and movement throughout the body of 18F-FMtl in healthy adult volunteers. It will be conducted ...
PAKMANN: Kinetics and Safety of [18F]-fluoromannitol
Study goal: To study the tolerance and safety of [18F]-fluoromannitol in healthy adult volunteers and to see how the tracer moves through their bodies.
[18F]-Fluoromannitol for Healthy Subjects
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 ...
Fluoromannitol PET Contrast Agent in Healthy Volunteers
This study focuses on understanding how a special imaging agent called 18F-Fluoromannitol (18F-FMtl) behaves in the body and checking its safety.
Imaging Diverse Pathogenic Bacteria In Vivo with 18F ...
18 F-fluoromannitol PET demonstrated high sensitivity and specificity for both gram-positive and gram-negative organisms in vivo.
Flouromannitol PET Imaging Agent (SJ-23-0039)
[18F]fluoromannitol can detect and differentiate infection rapidly and can be produced easily on commercial synthesizers to facilitate user accessibility and ...
Positron Emission Tomography Imaging with 2-[ 18 F]F-p ...
Therefore, 2-[18F]F-PABA has a high potential for a safe translation to humans to provide a rapid, noninvasive diagnostic tool to locate infections and guide ...
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