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Use of PET/MR Imaging in Chronic Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]FDG
PET/MRI
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Pain focused on measuring Positron emission tomography, Magnetic Resonance Imaging, PET/MRI, Fluorodeoxyglucose, FDG, Pain, Chronic Pain, Neuropathic Pain, Inflammatory Pain, Nociceptive Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18 years or older.
  • Chronic pain lasting greater than 2 months. For example: Low back pain, sciatica, complex regional pain syndrome, peripheral nerve injury, fibromyalgia, neuropathy, osteoarthritis, cancer pain, persistent post-operative pain, and migraine.
  • Provides informed consent
  • On a typical day, 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:

  • MRI-incompatible
  • Diabetes
  • Pregnant or nursing
  • Non-English speaker
  • Claustrophobic

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

[18F]FDG PET/MRI

Outcomes

Primary Outcome Measures

[18F]FDG PET/MRI as a spatial biomarker for chronic pain
Identification of structures with increased [18F]FDG uptake (SUVmax) corresponding to pain.

Secondary Outcome Measures

[18F]FDG Biodistribution in Healthy Subjects
We will use PET/MRI to establish the normal range of [18F]FDG uptake. (SUVmax) in various anatomic structures, such as the spinal cord, peripheral nerves, dorsal root ganglia, muscle, bones, joints, blood vessels, of asymptomatic subjects.
36 point Study Short-Form Health Survey
Patient-reported state of health.
Oswestry Disability Index
Measure of disability, quality of life.
Visual Analog Scale
A visual, semi-quantitative method for patient-derived self-assessment of pain intensity.

Full Information

First Posted
June 19, 2017
Last Updated
May 15, 2023
Sponsor
Stanford University
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03195270
Brief Title
Use of PET/MR Imaging in Chronic Pain
Official Title
Use of [18F]FDG PET/MRI in the Diagnosis of Pain Generators and/or Sites of Inflammation and to Monitor Treatment Effects in Patients With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 24, 2014 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
January 20, 2022 (Actual)

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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
The investigators are studying the ability of PET/MR imaging (using the PET tracer [18F]FDG) to objectively identify and characterize pain generators in patients suffering from chronic pain.
Detailed Description
The diagnosis and management of chronic and neuropathic pain syndromes remains a major clinical challenge, and this failure is partly attributed to our inability to identify the hypersensitive and inflammatory changes in the pain-sensing part of our nervous system that is thought to contribute to these syndromes. The lack of a specific, objective diagnostic test for chronic and neuropathic pain syndromes can result in a delay of diagnosis and suboptimal management decisions. This delay in diagnosis is quite unfortunate since the early diagnosis and treatment of a disease is attributed to the highest probability of remission in certain chronic pain syndromes. Additionally, identifying the correct source of pain is of paramount importance since the clinical course and therapeutic interventions are different depending on cause. Evidence in the literature points strongly toward an active inflammatory component in chronic pain. For example, soft tissue and bony inflammation is known to be an important pathophysiological mechanism for the symptoms of certain neuropathic pain syndromes. Similarly, individuals suffering from chronic sciatica or radiculopathy may suffer from a combination of inflammation and compression of lumbar or cervical spinal nerves. It is also established that inflammatory lesions have increased metabolism and energy requirements and, therefore, are more glucose-avid than normal tissues, showing increased uptake of radiolabeled glucose analogs, such as [18F]fluorodeoxyglucose ([18F]FDG). Correspondingly, [18F]FDG positron emission tomography-magnetic resonance imaging (PET/MRI) represent leading FDA-approved clinical imaging modalities to longitudinally study metabolic changes in the nervous system and non-neural tissues (e.g., muscle, blood vessels, joints, bone, scar tissue, etc.) in patients with chronic pain conditions. One of the goals of the study is to determine whether [18F]FDG PET/MRI can identify sources of inflammation with greater sensitivity, accuracy and objectivity than current diagnostic methods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Positron emission tomography, Magnetic Resonance Imaging, PET/MRI, Fluorodeoxyglucose, FDG, Pain, Chronic Pain, Neuropathic Pain, Inflammatory Pain, Nociceptive Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Participants will be recruited based on established criteria for chronic pain. For the PET/MRI scan, the participants will be injected with 10 mCi±1 mCi of [18F]FTC-146 via the antecubital vein in a bolus injection. PET and MRI scans will be acquired simultaneously using a hybrid PET/MRI scanner. Following the scan, participants will be contacted to check for adverse drug events, and any events will be recorded in the case report. The biodistribution of radiotracer will be analyzed using regions of interest (ROI) marked on anatomical structures on magnetic resonance images and quantifying the signal in PET images within the same ROIs. Pharmacokinetic information will be derived using mathematical modeling. Data from chronic pain patients will be compared to historical data from asymptomatic controls.
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
[18F]FDG PET/MRI
Intervention Type
Drug
Intervention Name(s)
[18F]FDG
Other Intervention Name(s)
[18F]Fluorodeoxyglucose
Intervention Description
10 mCi of [18F]FDG via the antecubital vein in a bolus injection
Intervention Type
Device
Intervention Name(s)
PET/MRI
Other Intervention Name(s)
Positron emission tomography/magnetic resonance imaging
Intervention Description
PET/MRI hybrid scanner used as diagnostic device
Primary Outcome Measure Information:
Title
[18F]FDG PET/MRI as a spatial biomarker for chronic pain
Description
Identification of structures with increased [18F]FDG uptake (SUVmax) corresponding to pain.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
[18F]FDG Biodistribution in Healthy Subjects
Description
We will use PET/MRI to establish the normal range of [18F]FDG uptake. (SUVmax) in various anatomic structures, such as the spinal cord, peripheral nerves, dorsal root ganglia, muscle, bones, joints, blood vessels, of asymptomatic subjects.
Time Frame
5 years
Title
36 point Study Short-Form Health Survey
Description
Patient-reported state of health.
Time Frame
5 years
Title
Oswestry Disability Index
Description
Measure of disability, quality of life.
Time Frame
5 years
Title
Visual Analog Scale
Description
A visual, semi-quantitative method for patient-derived self-assessment of pain intensity.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 years or older. Chronic pain lasting greater than 2 months. For example: Low back pain, sciatica, complex regional pain syndrome, peripheral nerve injury, fibromyalgia, neuropathy, osteoarthritis, cancer pain, persistent post-operative pain, and migraine. Provides informed consent On a typical day, 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: MRI-incompatible Diabetes Pregnant or nursing Non-English speaker Claustrophobic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feliks Kogan, PhD
Organizational Affiliation
Assistant Professor of Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is currently no plan to share the individual participant data with other researchers outside our group of researchers or referring physicians.
Citations:
PubMed Identifier
21764788
Citation
Behera D, Jacobs KE, Behera S, Rosenberg J, Biswal S. (18)F-FDG PET/MRI can be used to identify injured peripheral nerves in a model of neuropathic pain. J Nucl Med. 2011 Aug;52(8):1308-12. doi: 10.2967/jnumed.110.084731. Epub 2011 Jul 15.
Results Reference
background
PubMed Identifier
21311407
Citation
Do BH, Mari C, Tseng JR, Quon A, Rosenberg J, Biswal S. Pattern of 18F-FDG uptake in the spinal cord in patients with non-central nervous system malignancy. Spine (Phila Pa 1976). 2011 Oct 1;36(21):E1395-401. doi: 10.1097/BRS.0b013e31820a7df8.
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
PubMed Identifier
34718774
Citation
Yoon D, Xu Y, Cipriano PW, Alam IS, Mari Aparici C, Tawfik VL, Curtin CM, Carroll IR, Biswal S. Neurovascular, Muscle, and Skin Changes on [18F]FDG PET/MRI in Complex Regional Pain Syndrome of the Foot: A Prospective Clinical Study. Pain Med. 2022 Feb 1;23(2):339-346. doi: 10.1093/pm/pnab315.
Results Reference
derived

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Use of PET/MR Imaging in Chronic Pain

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