MRI Markers of Cartilage Damage in Knee With Osteoarthritis

American College of Radiology (ACR)

Status

Completed

Conditions

Osteoarthritis, Knee

Treatments

Other: Magnetic Resonance Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT00820430

ACRIN PA 4001

SAP #4100026182

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.