PET/MRI in the Diagnosis of Chronic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2024-12-31

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.

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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).

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pain Patients

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.

Group Type EXPERIMENTAL

[18F]FTC-146

Intervention Type DRUG

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

Healthy Volunteers

Individuals who do not have pain and undergo a \[18F\]FTC-146 PET/MRI scan.

Group Type EXPERIMENTAL

[18F]FTC-146

Intervention Type DRUG

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

Interventions

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[18F]FTC-146

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

Intervention Type DRUG

Other Intervention Names

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S1R

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes