Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT06171659

Conditions

Pain

Nociceptive Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

FDG radiotracer

PET/MRI

PET/CT imaging

Study Details

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

Study ID

NCT06171659

Start date

Nov 19, 2024

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

128 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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)

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)

Interventions

FDG 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.

PET/MRI

positron emission tomography and magnetic resonance imaging

PET/CT imaging

positron emission tomography and computed tomography imaging

Primary outcome measure

  • Change in SUVmax (chronic pain) [ Time Frame: baseline (6 months post-op), 12 months post-op, 18 months post-op ]
  • SUVmax (chronic pain vs healthy) [ Time Frame: baseline ]
  • Location of Pain Compared to Target-to-Background (TTB) or SUVmax [ Time Frame: baseline ]

Central Contacts and Locations

Central contacts

Radiology Studies

608-282-8349Radstudy@uwhealth.org

Locations

UW School of Medicine and Public Health

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-07-17.