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Completed

NCT Number: NCT03195270

Use of PET/MR Imaging in Chronic Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[18F]FDG

Drug

10 mCi of [18F]FDG via the antecubital vein in a bolus injection

Other names: [18F]Fluorodeoxyglucose

PET/MRI

Device

PET/MRI hybrid scanner used as diagnostic device

Other names: Positron emission tomography/magnetic resonance imaging

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • GE Healthcare

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2017
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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