PET/MRI in the Diagnosis of Chronic Pain
Primary Purpose
Neuropathic Pain, Nociceptive Pain, Mixed Pain (Nociceptive and Neuropathic)
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]FTC-146
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuropathic Pain focused on measuring PET/MRI, Chronic Pain
Eligibility Criteria
Inclusion Criteria:
Healthy Volunteers:
- At least 18 years old.
- 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:
- At least 18 years old.
- Chronic pain (nociceptive, neuropathic or mixed pain) lasting greater than 2 months.
- Pain level of at least 4/10 on a 0-10 Comparative Pain Scale.
- 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:
- Pain
- Pain Medication
- MRI incompatible
- Pregnant or nursing
- Non-English speaker
- Claustrophobic
Pain Patients:
- MRI incompatible
- Pregnant or nursing
- Non-English speaker
- Claustrophobic
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pain Patients
Healthy Volunteers
Arm Description
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.
Individuals who do not have pain and undergo a [18F]FTC-146 PET/MRI scan.
Outcomes
Primary Outcome Measures
[18F]FTC-146 Biodistribution in Healthy Volunteers
Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in healthy volunteers.
[18F]FTC-146 Biodistribution in Pain Patients
Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.
Secondary Outcome Measures
Full Information
NCT ID
NCT03556137
First Posted
June 2, 2018
Last Updated
July 18, 2023
Sponsor
Stanford University
Collaborators
GE Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT03556137
Brief Title
PET/MRI in the Diagnosis of Chronic Pain
Official Title
Use of [18F]FTC-146 PET/MRI in the Diagnosis of Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
GE Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Nociceptive Pain, Mixed Pain (Nociceptive and Neuropathic), Spinal Pain, Radiculopathy, Myelopathy, Neurogenic Claudication
Keywords
PET/MRI, Chronic Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pain Patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
Individuals who do not have pain and undergo a [18F]FTC-146 PET/MRI scan.
Intervention Type
Drug
Intervention Name(s)
[18F]FTC-146
Other Intervention Name(s)
S1R
Intervention Description
Adult participants will be injected with 5-10 mCi of [18F]FTC-146 and undergo a PET/MRI scan.
Primary Outcome Measure Information:
Title
[18F]FTC-146 Biodistribution in Healthy Volunteers
Description
Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in healthy volunteers.
Time Frame
Estimated average of 3 hours
Title
[18F]FTC-146 Biodistribution in Pain Patients
Description
Biodistribution of [18F]FTC-146 represented as Standardized Uptake Value max (SUVmax) in pain patients.
Time Frame
Estimated average of 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Volunteers:
At least 18 years old.
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:
At least 18 years old.
Chronic pain (nociceptive, neuropathic or mixed pain) lasting greater than 2 months.
Pain level of at least 4/10 on a 0-10 Comparative Pain Scale.
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:
Pain
Pain Medication
MRI incompatible
Pregnant or nursing
Non-English speaker
Claustrophobic
Pain Patients:
MRI incompatible
Pregnant or nursing
Non-English speaker
Claustrophobic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anand Veeravagu, MD
Phone
(650) 498-6154
Email
anand.veeravagu@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Adrian Valladarez
Email
adrian98@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Veeravagu, MD
Organizational Affiliation
Stanford University Department of Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Valladarez, BA
Email
adrian98@stanford.edu
First Name & Middle Initial & Last Name & Degree
Anand Veeravagu, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28824716
Citation
Shen B, Behera D, James ML, Reyes ST, Andrews L, Cipriano PW, Klukinov M, Lutz AB, Mavlyutov T, Rosenberg J, Ruoho AE, McCurdy CR, Gambhir SS, Yeomans DC, Biswal S, Chin FT. Visualizing Nerve Injury in a Neuropathic Pain Model with [18F]FTC-146 PET/MRI. Theranostics. 2017 Jul 8;7(11):2794-2805. doi: 10.7150/thno.19378. eCollection 2017.
Results Reference
background
PubMed Identifier
28572487
Citation
Hjornevik T, Cipriano PW, Shen B, Park JH, Gulaka P, Holley D, Gandhi H, Yoon D, Mittra ES, Zaharchuk G, Gambhir SS, McCurdy CR, Chin FT, Biswal S. Biodistribution and Radiation Dosimetry of 18F-FTC-146 in Humans. J Nucl Med. 2017 Dec;58(12):2004-2009. doi: 10.2967/jnumed.117.192641. Epub 2017 Jun 1.
Results Reference
background
PubMed Identifier
28280965
Citation
Shen B, Park JH, Hjornevik T, Cipriano PW, Yoon D, Gulaka PK, Holly D, Behera D, Avery BA, Gambhir SS, McCurdy CR, Biswal S, Chin FT. Radiosynthesis and First-In-Human PET/MRI Evaluation with Clinical-Grade [18F]FTC-146. Mol Imaging Biol. 2017 Oct;19(5):779-786. doi: 10.1007/s11307-017-1064-z.
Results Reference
background
PubMed Identifier
26384292
Citation
Shen B, James ML, Andrews L, Lau C, Chen S, Palner M, Miao Z, Arksey NC, Shuhendler AJ, Scatliffe S, Kaneshige K, Parsons SM, McCurdy CR, Salehi A, Gambhir SS, Chin FT. Further validation to support clinical translation of [(18)F]FTC-146 for imaging sigma-1 receptors. EJNMMI Res. 2015 Dec;5(1):49. doi: 10.1186/s13550-015-0122-2. Epub 2015 Sep 17.
Results Reference
background
PubMed Identifier
24337599
Citation
James ML, Shen B, Nielsen CH, Behera D, Buckmaster CL, Mesangeau C, Zavaleta C, Vuppala PK, Jamalapuram S, Avery BA, Lyons DM, McCurdy CR, Biswal S, Gambhir SS, Chin FT. Evaluation of sigma-1 receptor radioligand 18F-FTC-146 in rats and squirrel monkeys using PET. J Nucl Med. 2014 Jan;55(1):147-53. doi: 10.2967/jnumed.113.120261. Epub 2013 Dec 12.
Results Reference
background
PubMed Identifier
35295458
Citation
Yoon D, Fast AM, Cipriano P, Shen B, Castillo JB, McCurdy CR, Mari Aparici C, Lum D, Biswal S. Sigma-1 Receptor Changes Observed in Chronic Pelvic Pain Patients: A Pilot PET/MRI Study. Front Pain Res (Lausanne). 2021 Oct 20;2:711748. doi: 10.3389/fpain.2021.711748. eCollection 2021.
Results Reference
derived
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PET/MRI in the Diagnosis of Chronic Pain
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