MRI Markers of Cartilage Damage in Knee With Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by:
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT00820430
First received: January 9, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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
Osteoarthritis, Knee
Other: Magnetic Resonance Imaging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Multi-Center Trial on MR Image Markers of Knee Articular Cartilage Damage in Osteoarthritis

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820430

Locations
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
Principal Investigator: Timothy J Mosher, MD Milton S. Hershey Medical Center
Study Chair: Ravinder Reddy, PhD University of Pennsylvania, MMRRCC
  More Information

Additional Information:
No publications provided

Responsible Party: Timothy J. Mosher, MD, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00820430     History of Changes
Other Study ID Numbers: ACRIN PA 4001, SAP #4100026182
Study First Received: January 9, 2009
Last Updated: January 9, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by American College of Radiology Imaging Network:
osteoarthritis
knee
magnetic resonance imaging
knee cartilage
reproducibility

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014