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PET/MRI in the Diagnosis of Chronic Pain

Sponsor
Stanford University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03556137
Collaborator
GE Healthcare (Industry)
144
Enrollment
1
Location
2
Arms
70.5
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Use of [18F]FTC-146 PET/MRI in the Diagnosis of Chronic Pain
Actual Study Start Date :
Jul 16, 2018
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. [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.

    2. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Healthy Volunteers:
    1. At least 18 years old.
    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.

    Exclusion Criteria:
    Healthy Volunteers:

    1. Pain

    2. Pain Medication

    3. MRI incompatible

    4. Pregnant or nursing

    5. Non-English speaker

    Pain Patients:

    1. MRI incompatible

    2. Pregnant or nursing

    3. Non-English speaker

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University Stanford California United States 94305

    Sponsors and Collaborators

    • Stanford University
    • GE Healthcare

    Investigators

    • Principal Investigator: Sandip Biswal, MD, Stanford University Department of Radiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sandip Biswal, Associate Professor of Radiology, Stanford University
    ClinicalTrials.gov Identifier:
    NCT03556137
    Other Study ID Numbers:
    • 45332
    First Posted:
    Jun 14, 2018
    Last Update Posted:
    Jul 2, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sandip Biswal, Associate Professor of Radiology, Stanford University
    PET/MRI
    Chronic Pain
    Additional relevant MeSH terms:
    Neuralgia
    Chronic Pain
    Nociceptive Pain

    Study Results

    No Results Posted as of Jul 2, 2021