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NCT Number: NCT06063304

Quantitative MRI For Detection and Tracking of Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: 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.

Secondary outcomes

  1. 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

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. Calculate and compare the longitudinal changes in cartilage thickness at 3T and 7T over the 2 year period

    Time frame: at enrolment, after 6 months, after 12 months and after 24 months

    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.

  4. Calculate and compare the longitudinal changes in microstructure maps at 3T and 7T over the 2 year period

    Time frame: at enrolment, after 6 months, after 12 months and after 24 months

    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.

  5. Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with cartilage thickness

    Time frame: at enrolment, after 6 months, after 12 months and after 24 months

  6. Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with microstructure maps

    Time frame: at enrolment, after 6 months, after 12 months and after 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Neal K Bangerter, PhD

CONTACT

[email protected]

7534066791 ext. +44

Peter J Lally, PhD

CONTACT

[email protected]

7976905576 ext. +44

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Imperial College Healthcare NHS Trust

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2023
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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