Mixed Pain (Nociceptive and Neuropathic), Myelopathy, Neurogenic Claudication, Neuropathic Pain, Nociceptive Pain, Radiculopathy, Spinal Pain
Conditions
Keywords
PET/MRI, Chronic Pain
Brief 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).
Interventions
DRUG[18F]FTC-146
Adult participants will be injected with 5-10 mCi of \[18F\]FTC-146 and undergo a PET/MRI scan.
Sponsors
GE Healthcare
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy Volunteers: 1. At least 18 years old. 2. 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: 1. At least 18 years old. 2. Chronic pain (nociceptive, neuropathic or mixed pain) lasting greater than 2 months. 3. Pain level of at least 4/10 on a 0-10 Comparative Pain Scale. 4. 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: 1. Pain 2. Pain Medication 3. MRI incompatible 4. Pregnant or nursing 5. Non-English speaker 6. Claustrophobic Pain Patients: 1. MRI incompatible 2. Pregnant or nursing 3. Non-English speaker 4. Claustrophobic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [18F]FTC-146 Biodistribution in Healthy Volunteers | Estimated average of 3 hours | Biodistribution of \[18F\]FTC-146 represented as Standardized Uptake Value max (SUVmax) in healthy volunteers. |
| [18F]FTC-146 Biodistribution in Pain Patients | Estimated average of 3 hours | Biodistribution of \[18F\]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients. |
Countries
United States
Contacts
Primary ContactAnand Veeravagu, MD
Backup ContactAdrian Valladarez
Outcome results
None listed