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A Multi-Center Trial on MR Image Markers of Knee Articular Cartilage Damage in Osteoarthritis

18 Years
Not Enrolling
Osteoarthritis, Knee

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Trial Information

A Multi-Center Trial on MR Image Markers of Knee Articular Cartilage Damage in Osteoarthritis

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.

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

- 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.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

4 sequental MRI evaluations of the target knee within a 4-week period

Safety Issue:


Principal Investigator

Timothy J Mosher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Milton S. Hershey Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2006

Completion Date:

May 2008

Related Keywords:

  • Osteoarthritis, Knee
  • osteoarthritis
  • knee
  • magnetic resonance imaging
  • knee cartilage
  • reproducibility
  • Osteoarthritis
  • Osteoarthritis, Knee



Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033