PET/MRI in the Diagnosis of Pediatric Chronic Pain

Study Overview
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Brief Summary
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[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
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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.

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

Conditions
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Chronic Pain, Pediatric Disorder, Neuropathic Pain, Nociceptive Pain

Intervention / Treatment
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* Drug: [18F]FTC-146


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Pediatric Chronic Pain Patients
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/MRI, Pediatric Chronic Pain