Quantitative MRI For Detection And Tracking of Disease Progression Over 2 Years In Early Knee Osteoarthritis Patients & Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- 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
研究概览
简要总结
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:
- Compare the relative accuracies of 7T and 3T MRI in detecting clinical osteoarthritis progression.
- 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).
- Measure the repeatability of 7T and 3T quantitative MRI methods developed in whole-joint knee imaging
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
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
时间窗: 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.
次要结局
- 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)