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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 belowSelect...
I am between 11 and 18 years old.
Select...
I have been experiencing chronic pain for at least 2 months.
Select...
My pain level is at least 4 out of 10.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours
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).
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have an MRI due to compatibility issues.I am between 11 and 18 years old.I have been experiencing chronic pain for at least 2 months.You are afraid of small, enclosed spaces.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.
Research Study Groups:
This trial has the following groups:- Group 1: Pediatric Chronic Pain Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.