PET/MRI Scan for Pediatric Chronic Pain

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Stanford University

Disqualifiers: Pregnant, Nursing, Claustrophobic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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

I have been experiencing chronic pain for at least 2 months.

You must have received a negative Covid test result within 72 hours of the scan, regardless of your vaccination status.

My pain level is at least 4 out of 10.

Exclusion Criteria

You cannot have an MRI due to compatibility issues.

Non-English speaker

You are afraid of small, enclosed spaces.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET/MRI imaging using [18F]FTC-146 to identify and characterize pain pathways

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

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?

Group I: Pediatric Chronic Pain Patients Experimental Treatment 1 Intervention

Individuals 11-18 years old, with chronic pain (lasting at least 2 months).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

GE Healthcare

Industry Sponsor

Trials

307

Recruited

634,000+

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=p

PET/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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10629991/

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 ...

3. synapse.patsnap.com synapse.patsnap.com/drug/7e85c71171144bb08378c61869985c60

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 ...

4. stanfordhealthcare.org stanfordhealthcare.org/trials/p/NCT03556137.html

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.

5. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/1/NCT02753101.html

[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=p

PET/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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03195270

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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6944163/

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 ...

9. stanfordhealthcare.org stanfordhealthcare.org/trials/p/NCT04435821.html

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.