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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

[18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients [18F]FTC-146 Biodistribution in Pain Patients

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).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,387 Previous Clinical Trials

17,333,950 Total Patients Enrolled

4 Trials studying Neuropathic Pain

435 Patients Enrolled for Neuropathic Pain

GE HealthcareIndustry Sponsor

289 Previous Clinical Trials

630,956 Total Patients Enrolled

1 Trials studying Neuropathic Pain

190 Patients Enrolled for Neuropathic Pain

Helen R Nadel, MDPrincipal InvestigatorStanford University

Media Library

[18F]FTC-146 Clinical Trial Eligibility Overview. Trial Name: NCT04435821 — Phase 1

Neuropathic Pain Research Study Groups: Pediatric Chronic Pain Patients

Neuropathic 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I qualify to participate in this study?

"This experiment requires 100 participants who suffer from chronic agony that necessitates a pain score of at least 4/10 on the 0-10 Comparative Pain Scale. The age range for applicants is between 11 and 18 years old, with their affliction having endured no less than 2 months' duration."

Answered by AI

Is the age criterion for this research greater than two and a half decades?

"This clinical trial seeks to enrol children aged 11-18. There are 48 studies that cater specifically to the under 18 demographic, while a further 481 trials target those over 65 years old."

Answered by AI

Are there any vacancies left for individuals interested in this clinical trial?

"As per the clinicaltrials.gov page, this trial has concluded its recruitment phase. Initially posted on November 19th 2020 and last updated on June 30th 2021, it is not currently searching for any participants. Nevertheless, 545 other trials are actively recruiting patients at this time."

Answered by AI

Has the FDA granted authorization for [18F]FTC-146?

"The safety of [18F]FTC-146 was rated a 1 due to this being an early Phase 1 trial, which implies that there is only sparse data available on the drug's effectiveness and limited research into its safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PET/MRI in the Diagnosis of Pediatric Chronic Pain

Helen Ruth Nadel 2020. "PET/MRI in the Diagnosis of Pediatric Chronic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04435821.

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