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Use of PET/MR Imaging in Chronic Pain

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ClinicalTrials.gov Identifier: NCT03195270
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Sandip Biswal, Stanford University

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: [18F]FDG Device: PET/MRI Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 24, 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Single Arm
[18F]FDG PET/MRI
Drug: [18F]FDG
10 mCi of [18F]FDG via the antecubital vein in a bolus injection
Other Name: [18F]Fluorodeoxyglucose

Device: PET/MRI
PET/MRI hybrid scanner used as diagnostic device
Other Name: Positron emission tomography/magnetic resonance imaging




Primary Outcome Measures :
  1. [18F]FDG PET/MRI as a spatial biomarker for chronic pain [ Time Frame: 5 years ]
    Identification of structures with increased [18F]FDG uptake (SUVmax) corresponding to pain.


Secondary Outcome Measures :
  1. [18F]FDG Biodistribution in Healthy Subjects [ Time Frame: 5 years ]
    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.

  2. 36 point Study Short-Form Health Survey [ Time Frame: 5 years ]
    Patient-reported state of health.

  3. Oswestry Disability Index [ Time Frame: 5 years ]
    Measure of disability, quality of life.

  4. Visual Analog Scale [ Time Frame: 5 years ]
    A visual, semi-quantitative method for patient-derived self-assessment of pain intensity.



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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:

  • Age 18 years or older.
  • Clinically diagnosed chronic pain lasting greater than 2 months. Some example diagnoses include (but not limited to): Low back pain, sciatica, complex regional pain syndrome, post-traumatic pain, peripheral nerve injury, fibromyalgia, neuropathy, osteoarthritis, cancer pain, persistent post-operative pain, traumatic brain injury, pain from chronic cerebrospinal fluid leak, headache/migraine, chronic pruritus, rheumatologic disease, neuropathy (diabetic-induced, Charcot-Marie-Tooth, CIDP), etc.
  • Provides informed consent.
  • On a typical day, the subject must have a minimum pain level of 4 on a 0-10 Comparative Pain Scale.

Exclusion Criteria:

  • Presence of MRI-incompatible materials/devices.
  • Diabetes.
  • Severe claustrophobia.
  • Diagnosed psychiatric disorder that, in the opinion of the investigator, would impede participation in the study.
  • Pregnant or nursing.
  • Severe comorbid conditions.
  • Unable to read or complete questionnaires in English.
  • Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.

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): NCT03195270


Contacts
Contact: Sandip Biswal, MD 650-725-8018 biswal@stanford.edu
Contact: Peter W Cipriano, BA 650-380-3782 pciprian@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Sub-Investigator: Ian Carroll, MD         
Sub-Investigator: Catherine Curtin, MD         
Sub-Investigator: Vivanne Tawfik, MD, PhD         
Sub-Investigator: Matthew Smuck, MD         
Sub-Investigator: Ivan Cheng, MD         
Sub-Investigator: Stuart Goodman, MD, PhD         
Sub-Investigator: Erik Mittra, MD, PhD         
Sub-Investigator: DaeHyun Yoon, PhD         
Sub-Investigator: Garry Gold, MD         
Sponsors and Collaborators
Stanford University
GE Healthcare
Investigators
Principal Investigator: Sandip Biswal, MD Associate Professor of Radiology

Publications:
Responsible Party: Sandip Biswal, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT03195270     History of Changes
Other Study ID Numbers: IRB-24972
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is currently no plan to share the individual participant data with other researchers outside our group of researchers or referring physicians.

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

Keywords provided by Sandip Biswal, Stanford University:
Positron emission tomography
Magnetic Resonance Imaging
PET/MRI
Fluorodeoxyglucose
FDG
Pain
Chronic Pain
Neuropathic Pain
Inflammatory Pain
Nociceptive Pain

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action