MRI Markers of Cartilage Damage in Knee With Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820430
• Other study ID #: ACRIN PA 4001
• Secondary ID: SAP #4100026182
• Status: Completed
• Start date: November 2006
• Est. completion date: May 2008

Study information

• Verified date: July 2023
• Source: American College of Radiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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).

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology	Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		4 sequental MRI evaluations of the target knee within a 4-week period

External Links

•   Click here for more information about this study: ACRIN PA 4001, MRI Markers of Cartilage Damage in Knee With Osteoarthritis.