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临床试验/NCT02883907
NCT02883907已完成不适用

Advanced MR Imaging of Osteoarthritis

Cambridge University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Mean cartilage T1 relaxation time post gadolinium (milliseconds)

研究概览

简要总结

The utility of conventional imaging in the development of new treatments for osteoarthritis (OA) is hindered by:

  1. Difficulty in non-invasively evaluating the initial response to potential new treatment options. OA typically develops over a long time period, so evaluating the efficacy of new treatment options over a timeframe relevant to experimental medicine studies is difficult.
  2. Inadequate methods of disease quantification and stratification. OA is a heterogeneous condition and identifying which subgroups of patients are most likely to benefit from new treatments is crucial.

Novel magnetic resonance (MR) imaging acquisition and analysis techniques have the potential to solve these problems. However, their reliability needs to be fully established and knowledge of likely effect sizes is required to inform sample size considerations for further longitudinal/interventional studies.

This study aims to help address these issues by:

  1. Calculating effect sizes for MR measurements to inform sample size calculations for future studies.
  2. Assessing the reliability of a multiparametric MR protocol for assessment of the knee joint.

The investigators will examine a single knee of an initial 15 participants with MR. Participants will be drawn from two groups: (1) 10 participants aged 40-60 years old with clinical and x-ray features of OA and (2) 5 control subjects (matched to cases for age, sex and body mass index in a 1:2 ratio) who do not have clinical features of OA.

Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination.

This will allow us to assess both the reliability of our MR measurements and the expected progression in our MR measurements in OA subjects in the absence of any disease-modifying intervention.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Meets American College of Rheumatology (ACR) criteria for OA
  • Kellgren-Lawrence grade 2-3 OA on knee radiograph
  • Medial compartment predominant disease
  • Neutral alignment
  • Aged 40-60
  • Body Mass Index (BMI) < 35 kg per square meter
  • Ambulatory and in good general health
  • Group 2 Inclusion Criteria:
  • No current symptoms of knee pain or stiffness or other clinical features of OA
  • Aged 40-60
  • BMI < 35 kg per square meter
  • Ambulatory and in good general health
  • Exclusion Criteria (both groups):
  • History of ipsilateral lower limb fracture
  • History of ipsilateral lower limb surgery (including arthroscopy)
  • Metabolic bone disease
  • Inflammatory arthritis
  • Haematological malignancy
  • Paget's disease
  • Bone metastases
  • Contraindication to MR imaging (e.g. pacemaker, severe claustrophobia)
  • Contraindication to intravenous gadolinium based contrast medium administration (see 'Ethical Considerations' section)
  • Unable to consent

排除标准

  • 未提供

结局指标

主要结局

Mean cartilage T1 relaxation time post gadolinium (milliseconds)

时间窗: 1 year

Derived from delayed gadolinium enhanced MR of cartilage (dGEMRIC)

Mean cartilage T1rho relaxation time (milliseconds)

时间窗: 1 year

Mean cartilage T2 relaxation time (milliseconds)

时间窗: 1 year

次要结局

  • Cartilage thickness values (millimeters)(1 year)
  • Modified Osteoarthritis Knee Score (MOAKS) (arbitrary units)(1 year)
  • Dynamic contrast enhanced (DCE) quantitation of parameters(1 year)
  • Subchondral bone texture index (arbitrary units)(1 year)
  • Subchondral bone area (millimeters squared)(1 year)
  • Osteochondral junction integrity (semiquantitative grading, arbitrary units)(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamie MacKay

Clinical Research Fellow

Cambridge University Hospitals NHS Foundation Trust

研究点 (1)

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