Quantitative MRI For Detection and Tracking of Knee Osteoarthritis

Not yet recruiting

• Conditions: Knee Osteoarthritis

• Registration Number: NCT06063304
• Lead Sponsor: Imperial College London

Brief Summary

The goal of this observational study is to develop whole-joint quantitative MRI techniques that aid in the detection and tracking of osteoarthritis disease progression at 3T and 7T MRI scanners. The research objectives are:

1. Compare the relative accuracies of 7T and 3T MRI in detecting clinical osteoarthritis progression.

2. Compare the quantitative MRI measures developed with the results acquired from the following two questionnaires: Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Visual Analogue Score (VAS).

3. Measure the repeatability of 7T and 3T quantitative MRI methods developed in whole-joint knee imaging

4. Optimize the quality and efficiency of 7T and 3T whole-joint knee MRI

Participants will be scanned at the 3T scanner at the Clinical Imaging Facility at Hammersmith Hospital and/or the 7T scanner at the LOCUS Center at St Thomas' Hospital. Knee osteoarthritis volunteers will be asked to fill out two questionnaires and will be scanned 4 times over a 2 year period (at enrolment, after 6 months, after 12 months and after 24 months) while healthy volunteers will be scanned once at enrolment. Both healthy volunteers and knee osteoarthritis patients will be asked to fill out MRI safety forms before entering the scanner room, and both groups will be scanned up to 90 minutes during each session.

Researchers will compare knee osteoarthritis patients with healthy volunteers to see how their knee anatomy and tissue properties differ.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-26
• Last Update Submitted: 2023-09-26
• Study Start: 2023-10
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-02
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reproducibility of cartilage thickness values at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months	at enrolment, after 6 months, after 12 months and after 24 months	The cartilage thickness values will be calculated from the MRI scans that will be acquired.

Secondary Outcome Measures

Name	Time	Method
Reproducibility of microstructure maps at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months	at enrolment, after 6 months, after 12 months and after 24 months	The microstructure maps will be calculated from the MRI scans that will be acquired.
Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with cartilage thickness	at enrolment, after 6 months, after 12 months and after 24 months
Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with microstructure maps	at enrolment, after 6 months, after 12 months and after 24 months
Reproducibility of MOAKS analysis at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months	at enrolment, after 6 months, after 12 months and after 24 months	MRI Osteoarthritis Knee Score (MOAKS) values will be calculated from the MRI scans that will be acquired. MOAKS is a semi-quantitative scoring tool that scores sub-regions of articular cartilage and bone marrow lesions. Different grades are used to score each sub-region. For cartilage sub-region loss, grade 0 indicates no loss and grade 3 indicates over 75% loss.
Calculate and compare the longitudinal changes in cartilage thickness at 3T and 7T over the 2 year period	at enrolment, after 6 months, after 12 months and after 24 months	Cartilage thickness will be calculated for scans acquired at the various time points on the 3T and 7T scanners and compared with each other to investigate the change in thickness over the specified time frame.
Calculate and compare the longitudinal changes in microstructure maps at 3T and 7T over the 2 year period	at enrolment, after 6 months, after 12 months and after 24 months	Microstructure maps will be calculated for scans acquired at the various time points on the 3T and 7T scanners and compared with each other to investigate the change in thickness over the specified time frame.