PET/MRI Scan for Pediatric Chronic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to understand chronic pain in children using a special scan called PET/MRI. It focuses on sigma-1 receptors, which may contribute to long-lasting pain. The trial employs a substance called [18F]FTC-146 (a radiotracer) to help doctors better locate and understand pain sources. Children aged 11 to 18 who have experienced chronic pain for at least two months and have a pain level of at least 4 out of 10 may be suitable for this study. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants a chance to be among the first to receive this new approach.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this radiotracer is safe for pediatric patients?
Research has shown that [18F]FTC-146 is a promising substance for imaging tests to locate sigma-1 receptors in the body, which are associated with chronic pain. A study on [18F]FTC-146 indicated it is safe to use, with radiation exposure levels within acceptable limits. No major safety concerns have been reported for this compound, suggesting it is well-tolerated in imaging tests. However, as this trial is in an early stage, the focus remains on ensuring safety and determining the correct dose, so detailed information on long-term effects is not yet available.12345
Why are researchers excited about this trial?
Most treatments for pediatric chronic pain involve medications like acetaminophen, ibuprofen, or opioids, which work by reducing inflammation or altering pain perception. But [18F]FTC-146 works differently, targeting the sigma-1 receptor, a protein in the brain associated with pain modulation. Researchers are excited about this treatment because it offers a new mechanism of action that may provide relief without the side effects commonly associated with current pain medications. Moreover, the use of PET/MRI scans alongside this treatment could offer insights into the brain's response to pain, potentially leading to more personalized and effective pain management strategies for young patients.
What evidence suggests that this PET/MRI scan is effective for identifying chronic pain in pediatric patients?
Research has shown that \[18F\]FTC-146 is a promising tool for identifying areas in the body linked to chronic pain. It targets specific parts of cells called sigma-1 receptors, which are associated with long-lasting pain. Studies have found that \[18F\]FTC-146 can detect changes in these receptors, aiding in locating the source of pain. In this trial, \[18F\]FTC-146 will be used in PET/MRI scans to potentially highlight areas of inflammation or pain in pediatric patients. Although more research is needed, early results suggest it could aid in understanding and diagnosing chronic pain in children.16789
Who Is on the Research Team?
Helen R Nadel, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for children aged 11-18 with chronic pain, either neuropathic or nociceptive, lasting at least 2 months. They must have a pain level of at least 4/10 and can be vaccinated or unvaccinated against COVID-19 but need a negative test within 72 hours of the scan. It's not for those who are pregnant, nursing, non-English speakers, claustrophobic, or incompatible with MRI.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants undergo PET/MRI imaging using [18F]FTC-146 to identify and characterize pain pathways
Follow-up
Participants are monitored for safety and effectiveness after imaging
What Are the Treatments Tested in This Trial?
Interventions
- [18F]FTC-146
Trial Overview
[18F]FTC-146 is being tested to see if it can help find the source of chronic pain in kids using PET/MRI scans. This experimental radiotracer targets sigma-1 receptors which might play a role in ongoing pain conditions.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Individuals 11-18 years old, with chronic pain (lasting at least 2 months).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
GE Healthcare
Industry Sponsor
Fotis Vlachos
GE Healthcare
Chief Marketing Officer since 2024
PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania
Peter J. Arduini
GE Healthcare
Chief Executive Officer since 2022
MBA from Northwestern University, BSc in Marketing from Susquehanna University
Citations
1.
med.stanford.edu
med.stanford.edu/mosslab/research/clinicaltrial?ctid=NCT04435821&conditionId=&serviceLineId=&condition=&alpha=pPET/MRI in the Diagnosis of Pediatric Chronic Pain
\[18F\]FTC-146 is a sigma-1 receptor detector and is an experimental radiotracer. Several studies have implicated involvement of sigma-1 receptors in generation ...
A Practical Guide to Sigma-1 Receptor Positron Emission ...
We have developed a novel radioligand, [ 18 F]FTC-146, for highly specific in vivo PET/MRI detection of S1R upregulation in inflamed, painful ...
18F-FTC-146 - Drug Targets, Indications, Patents
18F-FTC-146 is among the most promising tools for σ-1 molecular imaging by positron emission tomography (PET), with a potential for application in clinical ...
PET/MRI in the Diagnosis of Chronic Pain
The purpose of this study is to compare the uptake of \[18F\]FTC-146 in healthy volunteers to that of individuals suffering from chronic pain. Official Title.
[18F]FTC-146 PET/MRI in Healthy Volunteers and in CRPS ...
The researchers may potentially identify the source of pain generation in patients suffering from complex regional pain syndrome (CRPS) and chronic sciatica.
6.
med.stanford.edu
med.stanford.edu/content/sm/ohns/research/clinical-trials-dynamic/clinical-trial-detail.html?ctid=NCT04435821&conditionId=&serviceLineId=&condition=&alpha=pPET/MRI in the Diagnosis of Pediatric Chronic Pain
\[18F\]FTC-146 is a sigma-1 receptor detector and is an experimental radiotracer. Several studies have implicated involvement of sigma-1 receptors in generation ...
NCT03195270 | Use of PET/MR Imaging in Chronic Pain
The investigators are studying the ability of PET/MR imaging (using the PET tracer [18F]FDG) to objectively identify and characterize pain generators in ...
Biodistribution and Radiation Dosimetry of 18F-FTC-146 in ...
Injection of 18F-FTC-146 is safe, and absorbed doses are acceptable. The potential of 18F-FTC-146 as an imaging agent for chronic pain and neuroinflammatory ...
PET/MRI in the Diagnosis of Pediatric Chronic Pain
Using 18F-FTC-146 and PET/MRI, we hope to learn what is the best approach to identify the source of pain generation and characterize the disease.
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