Clinical trial NCT06063304: Quantitative MRI For Detection and Tracking of Knee Osteoarthritis
Official title: Quantitative MRI For Detection And Tracking of Disease Progression Over 2 Years In Early Knee Osteoarthritis Patients & Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Healthy Volunteer
MRI
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2023-10-02
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: at enrolment, after 6 months, after 12 months and after 24 months
Secondary outcomes:
measure: 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
timeFrame: at enrolment, after 6 months, after 12 months and after 24 months
measure: 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
timeFrame: at enrolment, after 6 months, after 12 months and after 24 months
measure: Calculate and compare the longitudinal changes in cartilage thickness at 3T and 7T over the 2 year period
timeFrame: at enrolment, after 6 months, after 12 months and after 24 months
measure: Calculate and compare the longitudinal changes in microstructure maps at 3T and 7T over the 2 year period
timeFrame: at enrolment, after 6 months, after 12 months and after 24 months
measure: Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with cartilage thickness
timeFrame: at enrolment, after 6 months, after 12 months and after 24 months
measure: Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with microstructure maps
timeFrame: at enrolment, after 6 months, after 12 months and after 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College London
name: Neal K Bangerter, PhD
role: PRINCIPAL_INVESTIGATOR
References: