FDG PET/MR Imaging of Peripheral Pain Generators

NCT06171659 | Recruiting FDA Drug FDA Device

• 4 other identifiers: 2023-0884R01AR077706SMPH/RADIOLOGY/RADIOLOGYProtocol Version 11/1/2024
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to determine if a PET/MRI scan using FDG can accurately identify the source of chronic pain. Identifying the source of pain may help doctors treat chronic pain more effectively. Approximately 128 participants will be enrolled and can expect to be on study for up to 12 months.

Conditions

Pain; Nociceptive Pain

Outcome Measures

Primary Outcomes (3)

• Change in SUVmax (chronic pain)

  baseline (6 months post-op), 12 months post-op, 18 months post-op

• SUVmax (chronic pain vs healthy)

  baseline

• Location of Pain Compared to Target-to-Background (TTB) or SUVmax

  baseline

Secondary Outcomes (5)

• Number of Participants Where Standard FDG dose was sufficient to detect region of pain (symptomatic groups)

  baseline

• Variation of the maximum ratio of SUV (SUVRmax) in asymptomatic controls vs symptomatic

  baseline

• Variation of the maximum ratio of SUV (SUVRmax) in symptomatic participants

  baseline (6 months post-op), 12 months post-op, 18 months post-op

• Radiology Review Scores

  up to 18 months post-op

• Change in Pain Scores (chronic pain)

  baseline (6 months post-op), 12 months post-op, 18 months post-op

Study Arms (4)

Open Surgical Procedure (Arthroplasty)

PPSP subjects who have undergone hip (or knee) joint arthroplasty (i.e., open surgical procedure for joint replacement). * 6 month post-op scans * 12 month post-op scans * 18 month post-op scans

Drug: FDG radiotracer; Device: PET/MRI; Device: PET/CT imaging

Less Invasive Procedure (Arthroscopy)

PPSP subjects who have undergone hip (or knee) arthroscopy (i.e., less invasive joint surgical procedure involving scopes and lower profile surgical tools) \- 6 month post-op scans

Drug: FDG radiotracer; Device: PET/MRI; Device: PET/CT imaging

Asymptomatic: Had Total Joint Replacement (Arthroplasty)

Asymptomatic subjects who have undergone total hip or total knee arthroplasty. \- single scan during one study visit (up to 3.5 hours)

Drug: FDG radiotracer; Device: PET/MRI; Device: PET/CT imaging

Asymptomatic: Less Invasive Procedure (Arthroscopy)

Asymptomatic subjects who have undergone hip or knee arthroscopy. \- single scan during one study visit (up to 3.5 hours)

Drug: FDG radiotracer; Device: PET/MRI; Device: PET/CT imaging

Interventions

FDG radiotracer DRUG

Fludeoxyglucose F 18 Injection is a positron emitting radiopharmaceutical containing no-carrier added radioactive 2-deoxy-2-\[18F\]fluoro-D-g1ucose, which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET). It is administered by intravenous injection. Dosage planned 0.14 mCi/kg/patient.

Also known as: fluorodeoxyglucose, 18F-Fluorodeoxyglucose

Asymptomatic: Had Total Joint Replacement (Arthroplasty); Asymptomatic: Less Invasive Procedure (Arthroscopy); Less Invasive Procedure (Arthroscopy); Open Surgical Procedure (Arthroplasty)

PET/MRI DEVICE

positron emission tomography and magnetic resonance imaging

Asymptomatic: Had Total Joint Replacement (Arthroplasty); Asymptomatic: Less Invasive Procedure (Arthroscopy); Less Invasive Procedure (Arthroscopy); Open Surgical Procedure (Arthroplasty)

PET/CT imaging DEVICE

positron emission tomography and computed tomography imaging

Asymptomatic: Had Total Joint Replacement (Arthroplasty); Asymptomatic: Less Invasive Procedure (Arthroscopy); Less Invasive Procedure (Arthroscopy); Open Surgical Procedure (Arthroplasty)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with persistent post-surgical pain and asymptomatic individuals who have undergone joint arthroplasty (hip or knee) or joint arthroscopy (hip or knee).

You may qualify if:

• years old
• Presents with persistent pain with pain score of ≥4 on Numerical Rating Scale \[0:10\] for at least 6 months following joint arthroplasty or arthroscopy.
• Able and willing to provide informed consent
• Willing and able to undergo PET/MRI (arthroplasty and arthroscopy participants) and PET/CT (arthroplasty participants only)
• years old
• Asymptomatic (pain score of ≤2 on the NRS) for at least 6 months following joint arthroplasty or arthroscopy.
• Able and willing to provide informed consent
• Willing and able to undergo PET/MRI

You may not qualify if:

• Inability to understand and communicate with the investigators to complete the study-related questionnaires.
• Any co-morbidity which results in severe systemic disease limiting function as defined by the American Society of Anesthesiology (ASA) physical status classification \> 3, such as the presence of current or past (6 months) pulmonary, hepatic, renal disease, arthritis, hematopoietic, and neurological diseases not related to chronic pain.
• Pregnant or breastfeeding. (Individuals with childbearing potential will be asked to verbally confirm they are not pregnant. If they cannot confirm, they will have a urine pregnancy test either at the imaging study visit or within 7 days prior to the imaging study visit.)
• Subject with contraindication(s) to or inability to undergo PET/MRI
• Current diagnosis of malignancy of any kind. Participants in remission for at least two years and not undergoing any treatment may be considered per investigator discretion
• Current enrollment in a scientific interventional or treatment study.
• Subject unable or unwilling to provide informed consent

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Arthroscopy Association of North America (AANA): collaborator

Study Sites (1)

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Pain; Nociceptive Pain

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Sandip Biswal, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Studies

CONTACT

608-282-8349; Radstudy@uwhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 15, 2023
• Study Start: November 19, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)