PET/MRI in the Diagnosis of Chronic Pain

July 18, 2023 updated by: Anand Veeravagu, Stanford University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Anand Veeravagu, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: [18F]FTC-146
Adult participants will be injected with 5-10 mCi of [18F]FTC-146 and undergo a PET/MRI scan.
Other Names:
  • S1R
Experimental: Healthy Volunteers
Individuals who do not have pain and undergo a [18F]FTC-146 PET/MRI scan.
Drug: [18F]FTC-146
Adult participants will be injected with 5-10 mCi of [18F]FTC-146 and undergo a PET/MRI scan.
Other Names:
  • S1R

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
[18F]FTC-146 Biodistribution in Healthy Volunteers
Time Frame: Estimated average of 3 hours
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
Time Frame: Estimated average of 3 hours
Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.
Estimated average of 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Anand Veeravagu, MD, Stanford University Department of Neurosurgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 2, 2018

First Submitted That Met QC Criteria

June 2, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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