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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR077706 | U.S. NIH Grant/Contract | View source | |
| SMPH/RADIOLOGY/RADIOLOGY | Other Identifier | UW Madison | |
| Protocol Version 11/1/2024 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| Arthroscopy Association of North America | OTHER |
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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.
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.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Surgical Procedure (Arthroplasty) | PPSP subjects who have undergone hip (or knee) joint arthroplasty (i.e., open surgical procedure for joint replacement).
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| 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 |
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| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Where Standard FDG dose was sufficient to detect region of pain (symptomatic groups) | The standard administered adult dose of FDG currently used in clinics is 0.14 mCi/kg/patient. | baseline |
| Variation of the maximum ratio of SUV (SUVRmax) in asymptomatic controls vs symptomatic |
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Inclusion Criteria: Persistent Post-Surgical Pain Patients
Inclusion Criteria: Asymptomatic controls
Exclusion Criteria:
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Participants with persistent post-surgical pain and asymptomatic individuals who have undergone joint arthroplasty (hip or knee) or joint arthroscopy (hip or knee).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radiology Studies | Contact | 608-282-8349 | Radstudy@uwhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Sandip Biswal, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW School of Medicine and Public Health | Recruiting | Madison | Wisconsin | 53792 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059226 | Nociceptive Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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| PET/MRI | Device | positron emission tomography and magnetic resonance imaging |
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| PET/CT imaging | Device | positron emission tomography and computed tomography imaging |
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| 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 | 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. | up to 18 months post-op |
| Change in Pain Scores (chronic pain) | Pain will be evaluated on a scale of 0 (no pain) to 10 (worse possible pain). | baseline (6 months post-op), 12 months post-op, 18 months post-op |