PET/MRI in the Diagnosis of Chronic Pain

Study Overview
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Brief Summary
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Several studies have implicated involvement of sigma-1 receptors (SR1s) in the generation of chronic pain, while others are investigating anti SR1 drugs for treatment of chronic pain. Using [18F]-FTC-146 and positron emission tomography/magnetic resonance imaging (PET/MRI), the investigators hope to identify the source of pain generation in patients with chronic pain. The purpose of this study is to compare the uptake of [18F]FTC-146 in healthy volunteers to that of individuals suffering from chronic pain.

Detailed Description
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Chronic pain is a significant, widespread problem affecting every fifth person worldwide. Reported in 2011 by the Institute of Medicine, chronic pain affects 116 million American adults - more than the total number of individuals affected by heart disease, cancer, and diabetes combined. An estimated $635 billion each year is spent in the medical management of chronic pain and lost productivity. Better clinical methods to diagnose and localize pain are needed. The investigators have developed a S1R-specific radiotracer, [18F]FTC-146. Using imaging approaches to assess the location of S1R in pain may provide a tool to diagnose pain generators, monitor treatment response, and aid in the selection of patients for treatment. The goal is to use [18F]FTC-146 to image S1R expression in healthy volunteers and to compare the images to those individuals suffering from pain conditions in the following categories: (1) nociceptive pain (pain that results from tissue injury or inflammation), (2) neuropathic pain (pain that results from direct injury, disruption, impingement/compression or malfunction of the peripheral and/or central nervous system), and (3) mixed pain (pain that appears to have both nociceptive and neuropathic).

Official Title
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Use of [18F]FTC-146 PET/MRI in the Diagnosis of Chronic Pain

Conditions
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Neuropathic Pain, Nociceptive Pain, Mixed Pain (Nociceptive and Neuropathic), Spinal Pain, Radiculopathy, Myelopathy, Neurogenic Claudication

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Volunteers: At least 18 years old. Covid Vaccination status: Vaccinated or unvaccinated subjects who received a negative test result from the Covid test within 72 hours of the scan. Pain Patients: At least 18 years old. Chronic pain (nociceptive, neuropathic or mixed pain) lasting greater than 2 months. Pain level of at least 4/10 on a 0-10 Comparative Pain Scale. 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: Healthy Volunteers: Pain Pain Medication MRI incompatible Pregnant or nursing Non-English speaker Claustrophobic Pain Patients: MRI incompatible Pregnant or nursing Non-English speaker Claustrophobic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Patients<br>Individuals suffering from nociceptive pain, neuropathic pain, and mixed pain (pain that appears to be both nociceptive and neuropathic) and undergo a [18F]FTC-146 PET/MRI scan. | Drug: [18F]FTC-146<br>* Adult participants will be injected with 5-10 mCi of [18F]FTC-146 and undergo a PET/MRI scan.<br>* Other names: S1R;|
| Experimental: Healthy Volunteers<br>Individuals who do not have pain and undergo a [18F]FTC-146 PET/MRI scan. | Drug: [18F]FTC-146<br>* Adult participants will be injected with 5-10 mCi of [18F]FTC-146 and undergo a PET/MRI scan.<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 Healthy Volunteers | Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in healthy volunteers. | Estimated average of 3 hours | 
| [18F]FTC-146 Biodistribution in Pain Patients | Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients. | Estimated average of 3 hours | 

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