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Clinical Trials/NCT06063304
NCT06063304
Not Yet Recruiting
N/A

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

Imperial College London0 sites70 target enrollmentOctober 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Imperial College London
Enrollment
70
Primary Endpoint
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
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2023
End Date
September 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • 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)
  • 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)
  • Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with microstructure maps(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)
  • 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 microstructure maps at 3T and 7T over the 2 year period(at enrolment, after 6 months, after 12 months and after 24 months)

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