Skip to content

Quantitative MRI For Detection and Tracking of Knee Osteoarthritis

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06063304
Enrollment
70
Registered
2023-10-02
Start date
2023-10-31
Completion date
2026-09-30
Last updated
2023-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis, Healthy Volunteer, MRI

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.

Interventions

None listed

Sponsors

Imperial College Healthcare NHS Trust
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsat enrolment, after 6 months, after 12 months and after 24 monthsThe cartilage thickness values will be calculated from the MRI scans that will be acquired.

Secondary

MeasureTime frameDescription
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 monthsat enrolment, after 6 months, after 12 months and after 24 monthsMRI 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 periodat enrolment, after 6 months, after 12 months and after 24 monthsCartilage 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.
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 monthsat enrolment, after 6 months, after 12 months and after 24 monthsThe 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 thicknessat 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 mapsat enrolment, after 6 months, after 12 months and after 24 months
Calculate and compare the longitudinal changes in microstructure maps at 3T and 7T over the 2 year periodat enrolment, after 6 months, after 12 months and after 24 monthsMicrostructure 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.

Contacts

Primary ContactNeal K Bangerter, PhD
n.bangerter@imperial.ac.uk7534066791
Backup ContactPeter J Lally, PhD
p.lally@imperial.ac.uk7976905576

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026