PET/MRI in the Diagnosis of Pediatric Chronic Pain

NCT ID: NCT04435821

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-19
• Study Completion Date: 2024-10-31

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.

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.

Conditions

Chronic Pain; Pediatric Disorder; Neuropathic Pain; Nociceptive Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pediatric Chronic Pain Patients

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

Group Type: EXPERIMENTAL

[18F]FTC-146

Intervention Type: DRUG

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

Interventions

[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.

Intervention Type: DRUG

Other Intervention Names

S1R

Eligibility Criteria

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Helen Ruth Nadel

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen R Nadel, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

52830

Identifier Type: -

Identifier Source: org_study_id