Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
128 participants
OBSERVATIONAL
2024-11-19
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
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
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
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)
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
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)
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Arthroscopy Association of North America (AANA)
UNKNOWN
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Sandip Biswal, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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UW School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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SMPH/RADIOLOGY/RADIOLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 11/1/2024
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0884
Identifier Type: -
Identifier Source: org_study_id
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