RecruitingNCT06171659

FDG PET/MR Imaging of Peripheral Pain Generators

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


Sponsor

University of Wisconsin, Madison

Enrollment

128 participants

Start Date

Nov 19, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria8

  • 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

Exclusion Criteria7

  • 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

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Interventions

DRUGFDG radiotracer

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.

DEVICEPET/MRI

positron emission tomography and magnetic resonance imaging

DEVICEPET/CT imaging

positron emission tomography and computed tomography imaging


Locations(1)

UW School of Medicine and Public Health

Madison, Wisconsin, United States

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NCT06171659


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