跳至主要内容
临床试验/NCT01702870
NCT01702870Unknown不适用

Comparison of Magnetic Resonance (MR) Imaging Against Clinical Criteria in the Diagnosis and Monitoring of Adult Idiopathic Myopathy

University of Warwick3 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
70
试验地点
3
主要终点
MR signal (T1w, T2w and STIR sequences) in muscle.

研究概览

简要总结

A prospective observational study to determine the effectiveness of magnetic resonance (MR) imaging in the diagnosis and monitoring of idiopathic myopathy in adult humans.

详细描述

Idiopathic inflammatory myopathies are a heterogeneous group of conditions characterised by skeletal muscle inflammation leading to proximal muscle weakness, often with tenderness, and occasionally dermatological manifestations. Diagnosis is clinical and is based on the Bohan and Peter criteria which comprises clinical examination, serological markers, electromyography (EMG) and muscle biopsy. This has relatively poor sensitivity and specificity. Muscle biopsy in particular has a false negative rate of 10-15% and is invasive. Clinical criteria also lack the discriminatory power to differentiate between recurrent (or breakthrough) myopathy and myopathy secondary to treatment with corticosteroid.

Magnetic resonance (MR) imaging has the advantage of being non-invasive, and is able to discriminate between different tissues, and to identify areas of inflammation. The aim of this study is to assess the effectiveness of MR sequences in the diagnosis of myopathy, monitoring of treatment response, and in differentiating between breakthrough myopathy and steroid-induced myopathy.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any adult patient referred for an MR scan with a suspected clinical diagnosis of myopathy.

排除标准

  • Patient unable or unwilling to have an MR scan.
  • Standard MR exclusion criteria will apply.

结局指标

主要结局

MR signal (T1w, T2w and STIR sequences) in muscle.

时间窗: 2 years

The correlation between MR signal and the clinical criteria will be measured

次要结局

  • Correlation between MR appearances (T1w, T2w and STIR signal on MR)and the symptom severity (Bohan and Peter criteria)(2 years)
  • Difference in MR signal between myopathy and steroid-induced myopathy, with sensitivity and specificity(2 years)

研究者

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

Dr. Terence Jones

Clinical Research Fellow in Radiology

University of Warwick

研究点 (3)

Loading locations...

相似试验