NCT00820430

MRI Markers of Cartilage Damage in Knee With Osteoarthritis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: American College of Radiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2009-01-12
• Last updated: 2023-07-20

Locations

5 sites across 1 country: United States