Use of PET/MR Imaging in Chronic Pain

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195270
• Other study ID #: IRB-24972
• Status: Completed
• Phase: Phase 1
• Start date: November 24, 2014
• Est. completion date: January 20, 2022

Study information

• Verified date: May 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Device:
• PET/MRI
PET/MRI hybrid scanner used as diagnostic device

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	GE Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[18F]FDG PET/MRI as a spatial biomarker for chronic pain	Identification of structures with increased [18F]FDG uptake (SUVmax) corresponding to pain.	5 years
Secondary	[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.	5 years
Secondary	36 point Study Short-Form Health Survey	Patient-reported state of health.	5 years
Secondary	Oswestry Disability Index	Measure of disability, quality of life.	5 years
Secondary	Visual Analog Scale	A visual, semi-quantitative method for patient-derived self-assessment of pain intensity.	5 years