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Sponsors and Collaborators: |
American College of Radiology Imaging Network Pennsylvania Department of Health |
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Information provided by: | American College of Radiology Imaging Network |
ClinicalTrials.gov Identifier: | NCT00820430 |
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.
Condition | Intervention |
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Osteoarthritis, Knee |
Other: Magnetic Resonance Imaging |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | A Multi-Center Trial on MR Image Markers of Knee Articular Cartilage Damage in Osteoarthritis |
Enrollment: | 53 |
Study Start Date: | November 2006 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Control--Non-Osteoporotic Knee
Kellgren-Lawrence (KL) scale score of 0, Age: 18-35 years
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Other: Magnetic Resonance Imaging
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).
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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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Other: Magnetic Resonance Imaging
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).
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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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Other: Magnetic Resonance Imaging
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).
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Penn State Milton S. Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 | |
Thomas Jefferson University Hospital | |
Philadelphia, Pennsylvania, United States, 19017 | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Timothy J Mosher, MD | Milton S. Hershey Medical Center |
Study Chair: | Ravinder Reddy, PhD | University of Pennsylvania, MMRRCC |
Responsible Party: | Penn State Milton S. Hershey Medical Center ( Timothy J. Mosher, MD ) |
Study ID Numbers: | ACRIN PA 4001, SAP #4100026182 |
Study First Received: | January 9, 2009 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00820430 |
Health Authority: | United States: Institutional Review Board |
osteoarthritis knee magnetic resonance imaging knee cartilage reproducibility |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |