PET/MRI in the Diagnosis of Pediatric Chronic Pain

NCT04435821 | Completed Phase 1 FDA Drug

• 1 other identifier: 52830
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

\[18F\]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.

Conditions

Chronic Pain; Pediatric Disorder; Neuropathic Pain; Nociceptive Pain

Keywords

PET/MRI; Pediatric Chronic Pain

Outcome Measures

Primary Outcomes (1)

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

  Biodistribution of \[18F\]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.

  3 hours

Study Arms (1)

Pediatric Chronic Pain Patients

EXPERIMENTAL

Individuals 11-18 years old, with chronic pain (lasting at least 2 months).

Drug: [18F]FTC-146

Interventions

[18F]FTC-146 DRUG

Participants will be injected with 0.08 mCi/kg \[18F\]FTC-146. A whole-body PET/MRI scan will be performed after injection.

Also known as: S1R

Pediatric Chronic Pain Patients

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old.
• Chronic pain (nociceptive, neuropathic or mixed pain) lasting at least 2 months.
• Pain level of at least 4/10 on a 0-10 Comparative Pain Scale (reported at time of screening).
• Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan.

You may not qualify if:

• MRI incompatible
• Pregnant or nursing
• Non-English speaker
• Claustrophobic

Sponsors & Collaborators

• Stanford University: lead
• GE Healthcare: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Chronic Pain; Neuralgia; Nociceptive Pain

Interventions

6-(3-fluoropropyl)-3-(2-(azepan-1-yl)ethyl)benzo(d)thiazol-2(3H)-one

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Helen R Nadel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Pediatric Chronic Pain Patients

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 17, 2020
• Study Start: November 19, 2020
• Primary Completion: December 31, 2022
• Study Completion: October 31, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)