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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

\[18F\]FTC-146 is a sigma-1 receptor detector and is an experimental radiotracer. Several studies have implicated involvement of sigma-1 receptors in generation and perpetuation of chronic pain conditions, while others are investigating anti sigma-1 receptor drugs for treatment of 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 in pediatric patients with chronic pain.

Research Team

Helen R Nadel, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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