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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
2,473 Previous Clinical Trials
17,501,780 Total Patients Enrolled
39 Trials studying Chronic Pain
9,394 Patients Enrolled for Chronic Pain
GE HealthcareIndustry Sponsor
297 Previous Clinical Trials
633,546 Total Patients Enrolled
2 Trials studying Chronic Pain
278 Patients Enrolled for Chronic Pain
Helen R Nadel, MDPrincipal InvestigatorStanford University

Media Library

[18F]FTC-146 Clinical Trial Eligibility Overview. Trial Name: NCT04435821 — Phase 1
Chronic Pain Research Study Groups: Pediatric Chronic Pain Patients
Chronic 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
~2 spots leftby Dec 2024
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