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PET/MRI Scan for Pediatric Chronic Pain

Phase 1
Waitlist Available
Led By Helen R Nadel, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
11-18 years old
Chronic pain (nociceptive, neuropathic or mixed pain) lasting at least 2 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to detect and treat chronic pain in children.

Who is the study for?
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.
What is being tested?
[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.
What are the potential side effects?
As [18F]FTC-146 is an experimental drug and used as a diagnostic tool rather than treatment, specific side effects aren't detailed here but may include reactions related to PET/MRI procedures such as discomfort from lying still.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 11 and 18 years old.
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I have been experiencing chronic pain for at least 2 months.
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My pain level is at least 4 out of 10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
[18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pediatric Chronic Pain PatientsExperimental Treatment1 Intervention
Individuals 11-18 years old, with chronic pain (lasting at least 2 months).

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,484 Previous Clinical Trials
17,516,021 Total Patients Enrolled
2 Trials studying Nociceptive Pain
390 Patients Enrolled for Nociceptive Pain
GE HealthcareIndustry Sponsor
301 Previous Clinical Trials
633,788 Total Patients Enrolled
1 Trials studying Nociceptive Pain
190 Patients Enrolled for Nociceptive Pain
Helen R Nadel, MDPrincipal InvestigatorStanford University
Sandip Biswal, MDPrincipal InvestigatorStanford University
4 Previous Clinical Trials
430 Total Patients Enrolled
2 Trials studying Nociceptive Pain
318 Patients Enrolled for Nociceptive Pain

Media Library

[18F]FTC-146 Clinical Trial Eligibility Overview. Trial Name: NCT04435821 — Phase 1
Nociceptive Pain Research Study Groups: Pediatric Chronic Pain Patients
Nociceptive Pain Clinical Trial 2023: [18F]FTC-146 Highlights & Side Effects. Trial Name: NCT04435821 — Phase 1
[18F]FTC-146 2023 Treatment Timeline for Medical Study. Trial Name: NCT04435821 — Phase 1
~0 spots leftby Dec 2024