PET/MRI in the Diagnosis of Pediatric Chronic Pain

Use of PET/MRI in the Diagnosis of Pediatric Chronic Pain

[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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Neuropathic Pain; Pediatric Disorder; Nociceptive Pain
• Intervention / Treatment: Drug: [18F]FTC-146

Detailed Description

It is estimated that 20% to 35% of children and adolescents worldwide are affected by chronic pain. As a result of chronic pain, children may miss school, withdraw from social activities, and develop internalizing behaviors. Therefore, accurately identifying the cause of a child's pain is important for both proper treatment of the pain and to prevent problems secondary to the chronic pain. Evidence in the literature points strongly toward an involvement of the sigma-1 receptor in neurogenic inflammation, which is known to be an important pathophysiological mechanism for maintenance and perpetuation of chronic neuropathic pain. The investigators hope to image and identify activated pain pathways in pediatric pain paitents using a radiolabeled biomarker for increased S1R expression. By localizing and quantifying areas of increased S1R expression to sites of augmented nociceptive activity using hybrid molecular/anatomic imaging techniques, we will objectively identify sites of neurogenic inflammatory activity and pain generation. The ability to image the changes associated with chronic pain generating pathologies provides us with a tool to identify and measure the intensity of the pathology. Imaging S1R expression in chronic pain states in pediatric patients would be both novel in its application and extremely powerful in better characterizing pediatric pain.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 11-18 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pediatric Chronic Pain Patients; Individuals 11-18 years old, with chronic pain (lasting at least 2 months).	Drug: [18F]FTC-146; Participants will be injected with 0.08 mCi/kg [18F]FTC-146. A whole-body PET/MRI scan will be performed after injection.; Other Names: S1R

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Helen R Nadel, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 15, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: PET/MRI; Pediatric Chronic Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Chronic Pain; Neuralgia; Nociceptive Pain
• Other Study ID Numbers: 52830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No