Quantitative MRI For Detection and Tracking of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Quantitative MRI For Detection And Tracking of Disease Progression Over 2 Years In Early Knee Osteoarthritis Patients & Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06063304
• Other study ID #: 22IC8098
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: September 2026

Study information

• Verified date: September 2023
• Source: Imperial College London
• Contact: Neal K Bangerter, PhD
• Phone: 7534066791
• Email: n.bangerter[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria For Healthy Volunteers:

• All people between 40 to 70 years of age
• All people with no history of knee injury, surgery, or knee pain

Exclusion Criteria For Healthy Volunteers:

• Patients with body mass index of more than 35, or body geometry that prevents scanning due to MRI scanner bore width or knee coil diameter
• Patients with varus or valgus malalignment
• Patients with contraindications to MRI
• Patients lacking capacity to consent
• Patients who are pregnant or breast-feeding
• Patients who are participating in a clinical trial(s) for new drugs and/or therapies

Inclusion Criteria for Knee Osteoarthritis Patients:

• All patients with primary osteoarthritis (grade 2-3 per Kellgren-Lawrence Scale)
• Patients who have had radiographs taken as part of their routine clinical care agreed with their orthopaedic surgeon, Mr Gareth Jones. Note that their radiographs must have been acquired a maximum of three weeks from the first, baseline scanning session. This radiograph will be used to check if patients have primary osteoarthritis.
• All patients between 40 to 70 years of age Exclusion Criteria for Knee Osteoarthritis Patients
• Patients with body mass index of more than 35, or body geometry that prevents scanning due to MRI scanner bore width or knee coil diameter
• Patients with varus or valgus malalignment of more than 5°
• Patients with radiographic osteoarthritis (grade =4 per Kellgren-Lawrence Scale, obtained from radiographs)
• Patients with contraindications to MRI
• Patients lacking capacity to consent
• Patients who are pregnant or breast-feeding
• Patients who are participating in a clinical trial(s) for new drugs and/or therapies

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Imperial College Healthcare NHS Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The cartilage thickness values will be calculated from the MRI scans that will be acquired.	at enrolment, after 6 months, after 12 months and after 24 months
Secondary	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	The microstructure maps will be calculated from the MRI scans that will be acquired.	at enrolment, after 6 months, after 12 months and after 24 months
Secondary	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	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.	at enrolment, after 6 months, after 12 months and after 24 months
Secondary	Calculate and compare the longitudinal changes in cartilage thickness at 3T and 7T over the 2 year period	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.	at enrolment, after 6 months, after 12 months and after 24 months
Secondary	Calculate and compare the longitudinal changes in microstructure maps at 3T and 7T over the 2 year period	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.	at enrolment, after 6 months, after 12 months and after 24 months
Secondary	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
Secondary	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