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PET/MRI in the Diagnosis of Chronic Pain

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ClinicalTrials.gov Identifier: NCT03556137
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : July 2, 2021
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Sandip Biswal, Stanford University

Study Description
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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
Neuropathic Pain Nociceptive Pain MIxed Pain (Nociceptive and Neuropathic) Drug: [18F]FTC-146 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 16, 2018
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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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 Name: 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 Name: S1R


Outcome Measures
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Primary Outcome Measures :
  1. [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.

  2. [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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556137


Contacts
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Contact: Sandip Biswal, MD (650) 498-4561 biswal@stanford.edu
Contact: Sunyoung Park sydoit@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Sunyoung Park, BA       sydoit@stanford.edu   
Principal Investigator: Sandip Biswal, MD         
Sponsors and Collaborators
Stanford University
GE Healthcare
Investigators
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Principal Investigator: Sandip Biswal, MD Stanford University Department of Radiology
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sandip Biswal, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT03556137    
Other Study ID Numbers: 45332
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandip Biswal, Stanford University:
PET/MRI
Chronic Pain
Additional relevant MeSH terms:
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Neuralgia
Chronic Pain
Nociceptive Pain
Pain
 Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases