Use of PET/MR Imaging in Chronic Pain

Phase 1

Completed

• Conditions: Chronic Pain
• Interventions: Drug: [18F]FDG; Device: PET/MRI

• Registration Number: NCT03195270
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-11-24
• Study First Submitted: 2017-06-19
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-22
• Primary Completion: 2022-01-20
• Study Completion: 2022-01-20
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	PET/MRI	\[18F\]FDG PET/MRI
Single Arm	[18F]FDG	\[18F\]FDG PET/MRI

Primary Outcome Measures

Name	Time	Method
[18F]FDG PET/MRI as a spatial biomarker for chronic pain	5 years	Identification of structures with increased \[18F\]FDG uptake (SUVmax) corresponding to pain.

Secondary Outcome Measures

Name	Time	Method
[18F]FDG Biodistribution in Healthy Subjects	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.
36 point Study Short-Form Health Survey	5 years	Patient-reported state of health.
Oswestry Disability Index	5 years	Measure of disability, quality of life.
Visual Analog Scale	5 years	A visual, semi-quantitative method for patient-derived self-assessment of pain intensity.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States