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MRI Markers of Cartilage Damage in Knee With Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00820430
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : January 12, 2009
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by:
American College of Radiology Imaging Network

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Osteoarthritis, Knee Other: Magnetic Resonance Imaging

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Multi-Center Trial on MR Image Markers of Knee Articular Cartilage Damage in Osteoarthritis
Study Start Date : November 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Control--Non-Osteoporotic Knee
Kellgren-Lawrence (KL) scale score of 0, Age: 18-35 years
 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).
Other Names:
  • MRI
  • knee MRI
  • knee magnetic resonance imaging
Minimal Osteoarthritis, Knee
Kellgren-Lawrence (KL) scale score of 1 or 2, Age: Older than 18; no upper limit
 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).
Other Names:
  • MRI
  • knee MRI
  • knee magnetic resonance imaging
Moderate Osteoarthritis, Knee
Kellgren-Lawrence (KL) scale score of 3, Age: Older than 18; no upper limit
 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).
Other Names:
  • MRI
  • knee MRI
  • knee magnetic resonance imaging


Outcome Measures
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Primary Outcome Measures :
  1. 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. [ Time Frame: 4 sequental MRI evaluations of the target knee within a 4-week period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Participants must be >18 years old;
  • Participants must have a KL score between 0 and 3;
  • Participants must have clearance to use protocol specified equipment: 3T MRI with parallel imaging capability and phased array knee coil (minimum 4 elements);
  • Participant had no change of treatment occur within the last 6 months;
  • Participants have no plans of changing to a different treatment within the next 3 months;
  • Participant must provide a study-specific signed informed consent form.

Exclusion Criteria:

  • Patients with contraindication to 3T MRI: Claustrophobia, Implanted metal or medical device that is not approved for MRI scanning at 3T, pregnancy, inability to tolerate relative immobility for 1 hour;
  • Patients with prior knee surgery or trauma of the knee;
  • Patients with KL score of 4.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820430


Locations
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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
Sponsors and Collaborators
American College of Radiology Imaging Network
Pennsylvania Department of Health
Investigators
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Principal Investigator: Timothy J Mosher, MD Milton S. Hershey Medical Center
Study Chair: Ravinder Reddy, PhD University of Pennsylvania, MMRRCC
More Information
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Responsible Party: Timothy J. Mosher, MD, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00820430    
Other Study ID Numbers: ACRIN PA 4001
SAP #4100026182
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: January 12, 2009
Last Verified: January 2009
Keywords provided by American College of Radiology Imaging Network:
osteoarthritis
knee
magnetic resonance imaging
knee cartilage
reproducibility
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases