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| ID | Type | Description | Link |
|---|---|---|---|
| SAP #4100026182 |
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| Name | Class |
|---|---|
| Pennsylvania Department of Health | OTHER_GOV |
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The objectives of this study are: to identify and develop techniques to minimize precision errors in magnetic resonance imaging (MRI) evaluation of knee cartilage, and to determine if results from newly-identified MRI techniques in measuring cartilage changes and structure can be reproduced.
The development of a disease modifying osteoarthritis drugs (DMOADs) is currently limited by the inability to detect and monitor early cartilage damage that would be amenable to treatment. There is growing interest within the pharmaceutical and research community to use Magnetic Resonance Imaging (MRI) to identify biochemical and structural changes in the cartilage extra cellular matrix that occur early in the disease process. Although these techniques have been validated in small studies at single sites, multi-center evaluation of accuracy and precision, needed to apply these techniques to clinical trials of DMOADs, has not been performed. To address this need, the primary objective for this protocol is to identify and develop techniques to minimize systematic errors that decrease precision of MRI evaluation of knee cartilage, and to assess the reproducibility of the newly identified MRI techniques in measuring the cartilage morphometry and structure. Successful completion of this project may establish a multi-center imaging network in Pennsylvania for MRI evaluation of potential disease modifying osteoarthritis drugs (DMOADs) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control--Non-Osteoporotic Knee | Kellgren-Lawrence (KL) scale score of 0, Age: 18-35 years |
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| Minimal Osteoarthritis, Knee | Kellgren-Lawrence (KL) scale score of 1 or 2, Age: Older than 18; no upper limit |
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| Moderate Osteoarthritis, Knee | Kellgren-Lawrence (KL) scale score of 3, Age: Older than 18; no upper limit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Other | Subjects will undergo 4 sequential MRI evaluations of the target knee within a 4 week period to calculate precision error (ICC) in determination of cartilage morphometry (cartilage volume, mean thickness, and surface area), cartilage collagen (regional cartilage T2), and cartilage proteoglycan (regional cartilage T1rho). |
| Measure | Description | Time Frame |
|---|---|---|
| The primary study goals are to develop and evaluate MRI techniques that minimize systematic errors in measuring knee cartilage, and to assess the reproducibility of MRI techniques comparing normal and osteoarthritic knees across institutions. | 4 sequental MRI evaluations of the target knee within a 4-week period |
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Inclusion Criteria:
Exclusion Criteria:
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This multi-center trial comprises only facilities within Pennsylvania. Study participants for the normal cohorts will be recruited through print flyers. It is anticipated that the study participants with mild to moderate OA will be identified by the radiologists interpreting the knee x-rays.
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| Name | Affiliation | Role |
|---|---|---|
| Timothy J Mosher, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Ravinder Reddy, PhD | University of Pennsylvania, MMRRCC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States | ||
| Thomas Jefferson University Hospital |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Philadelphia |
| Pennsylvania |
| 19017 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |