Quantitative MRI For Detection and Tracking of Knee Osteoarthritis

NCT ID: NCT06063304

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2026-09-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neal K Bangerter, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Central Contacts

Neal K Bangerter, PhD

Role: CONTACT

n.bangerter@imperial.ac.uk

7534066791 ext. +44

Peter J Lally, PhD

Role: CONTACT

p.lally@imperial.ac.uk

7976905576 ext. +44

Other Identifiers

22IC8098

Identifier Type: -

Identifier Source: org_study_id