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NCT Number: NCT06171659

FDG PET/MR Imaging of Peripheral Pain Generators

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UW School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location status: Recruiting

About this study

The investigators aim to precisely localize sites of increased inflammation and potentially pain generation and improve understanding of nociception and inflammation using a unique, hybrid PET/MRI approach in conjunction with intravenously, administered fluorodeoxyglucose (FDG), which has been shown with PET imaging to be an sensitive surrogate marker of inflammation.

The Primary Objective of this pilot prospective, observational research is to determine whether this approach, which combines PET/MRI and an FDA-approved radiotracer, 18F-Fluorodeoxyglucose (FDG), can accurately localize the sites of painful inflammation in individuals with persistent pain.

  • Determine if increased FDG uptake on PET as measured by standard uptake value (SUV) or target-to-background (TTB) measurements is increased in area of pain symptoms when compared to same corresponding areas in healthy, asymptomatic volunteers.
  • Determine whether amount of FDG uptake as measured on PET is able to localize to abnormalities when compared to MR imaging (T2 signal intensity, morphologic aberrations)

Secondary Objectives:

  • Verify that the standard administered adult dose of FDG (0.14 mCi/kg/patient) used currently in the clinics can also be used to detect peripheral pain generators.
  • Verify that FDG uptake in asymptomatic, healthy controls will be significantly less than their chronic pain cohorts at the same anatomic location.
  • Determine whether longitudinal FDG PET/MR imaging findings in individual patients directly correlate with symptoms as they evolve over time in joint arthroplasty subjects with PPSP.
  • Determine if FDG PET/MR imaging findings spatially differ between different pain types.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Persistent Post-Surgical Pain Patients

  • 18-85 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)

Inclusion criteria

Asymptomatic controls

  • 18-85 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: fluorodeoxyglucose, 18F-Fluorodeoxyglucose

PET/MRI

Device

positron emission tomography and magnetic resonance imaging

PET/CT imaging

Device

positron emission tomography and computed tomography imaging

Primary outcomes

  1. Change in SUVmax (chronic pain)

    Time frame: baseline (6 months post-op), 12 months post-op, 18 months post-op

  2. SUVmax (chronic pain vs healthy)

    Time frame: baseline

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

    Time frame: baseline

Secondary outcomes

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

    Time frame: baseline

    The standard administered adult dose of FDG currently used in clinics is 0.14 mCi/kg/patient.

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

    Time frame: baseline

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

    Time frame: baseline (6 months post-op), 12 months post-op, 18 months post-op

  4. Radiology Review Scores

    Time frame: up to 18 months post-op

    Radiologists will evaluate MRI and CT images from each exam, and assign 1 point to any abnormality detected in the following compartments: prosthesis itself, bone, joint space, joint capsule, muscle, subcutaneous fat, and skin, for a total of 7 possible points. Differences in scoring from MRI vs CT images will be further investigated with a t-test.

  5. Change in Pain Scores (chronic pain)

    Time frame: baseline (6 months post-op), 12 months post-op, 18 months post-op

    Pain will be evaluated on a scale of 0 (no pain) to 10 (worse possible pain).

Study contacts

Contact information is provided by the study sponsor or research team.

Radiology Studies

CONTACT

[email protected]

608-282-8349

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Arthroscopy Association of North America
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

FDG PET/MR Imaging of Peripheral Pain Generators in Persistent Post-Surgical Pain (PPSP)

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 15, 2023
Registry last updated
Jul 17, 2026

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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