Use of PET/MR Imaging in Chronic Pain

NCT03195270 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB-24972
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Positron emission tomography; Magnetic Resonance Imaging; PET/MRI; Fluorodeoxyglucose; FDG; Pain; Chronic Pain; Neuropathic Pain; Inflammatory Pain; Nociceptive Pain

Outcome Measures

Primary Outcomes (1)

• [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 Outcomes (4)

• [18F]FDG Biodistribution in Healthy Subjects

  5 years

• 36 point Study Short-Form Health Survey

  5 years

• Oswestry Disability Index

  5 years

• Visual Analog Scale

  5 years

Study Arms (1)

Single Arm

EXPERIMENTAL

\[18F\]FDG PET/MRI

Drug: [18F]FDG; Device: PET/MRI

Interventions

[18F]FDG DRUG

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

Also known as: [18F]Fluorodeoxyglucose

Single Arm

PET/MRI DEVICE

PET/MRI hybrid scanner used as diagnostic device

Also known as: Positron emission tomography/magnetic resonance imaging

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• GE Healthcare: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (4)

• 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.

  PMID: 21764788 BACKGROUND

• 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.

  PMID: 21311407 BACKGROUND

• 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.

  PMID: 35295458 DERIVED

• 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.

  PMID: 34718774 DERIVED

MeSH Terms

Conditions

Chronic Pain; Pain; Neuralgia; Nociceptive Pain

Interventions

Fluorodeoxyglucose F18; Positron-Emission Tomography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Feliks Kogan, PhD

  Assistant Professor of Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 22, 2017
• Study Start: November 24, 2014
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)