Quantitative MRI For Detection and Tracking of Knee Osteoarthritis

NCT06063304 | Not Yet Recruiting

• 1 other identifier: 22IC8098
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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. 1.Compare the relative accuracies of 7T and 3T MRI in detecting clinical osteoarthritis progression.
2. 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. 3.Measure the repeatability of 7T and 3T quantitative MRI methods developed in whole-joint knee imaging
4. 4.Optimize the quality and efficiency of 7T and 3T whole-joint knee MRI

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Healthy Volunteer; MRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Healthy Volunteers

This group consists of healthy volunteers with no history of knee joint pain (refer to inclusion/exclusion criteria for more details). They will be scanned once and their scans will be used as the baseline to compare the early knee osteoarthritis patient data with. 10 healthy volunteers will be recruited.

Knee Osteoarthritis Patients

This group consists of early knee osteoarthritis patients (refer to inclusion/exclusion criteria for more details). They will be scanned 4 times over a period of 2 years (at enrolment, 6 months, 12 months and 24 months after enrolment) to see how the disease progresses. Their scans will be compared with the baseline healthy volunteer scans to check for any differences in anatomy and tissue properties. 60 knee osteoarthritis patients will be recruited.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research team will be recruiting both healthy volunteers and early knee osteoarthritis patients using the inclusion and exclusion criteria detailed above.

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Neal K Bangerter, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neal K Bangerter, PhD

CONTACT

7534066791; n.bangerter@imperial.ac.uk

Peter J Lally, PhD

CONTACT

7976905576; p.lally@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: October 2, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share