NCT03556137

PET/MRI in the Diagnosis of Chronic Pain

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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).

Conditions

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

Interventions

Type	Name	Description
DRUG	[18F]FTC-146	Adult participants will be injected with 5-10 mCi of \[18F\]FTC-146 and undergo a PET/MRI scan.

Timeline

• Start date: 2018-07-16
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-06-14
• Last updated: 2023-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study