An Open Label, Multicenter, Retrospective, Pivotal Trial to Evaluate the Efficacy of Clinical Decision Support System-mPDia for Neurodegenerative Parkinsonism Using MRI Images
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Heuron Inc.
- 入组人数
- 221
- 试验地点
- 10
- 主要终点
- Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism
研究概览
简要总结
mPDia is a software that has been pre-learned based on a neurodegenerative parkinsonism diagnosis model using Nigrosome 1 MRI images, and clinical decision support system for diagnosing neurodegenerative parkinsonism by automatically analyzing Nigrosome 1 MRI images by assisting the medical team.
The specific aims of this study are to evaluate efficacy of mPDia for neurodegenerative Parkinsonism compared to the sensitivity and specificity levels of 18F FP-CIT PET/CT which is currently used to diagnose neurodegenerative parkinsonism.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（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
- •Patients with other brain diseases except parkinsonism
- •Who have anatomical abnormality in MRIs etc.
- •Who have other causes of tremor(e.g., thyroid disease)
- •Patients with lesion in basal ganglia(e.g., vascular parkinsonism, hydrocephalus and Wilson's disease)
结局指标
主要结局
Sensitivity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism
时间窗: At Visit 2 (within 4 weeks after Visit 1)
Sensitivity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups). Sensitivity was calculated as TP/(TP+FN) Sensitivity: 100 x True positive(TP)/ \[True positive(TP) + False negative(FN)\] (%)
Specificity of mPDia for the Diagnosis of Neurodegenerative Parkinsonism
时间窗: At Visit 2 (within 4 weeks after Visit 1)
Specificity of mPDia in diagnosing neurodegenerative parkinsonism, based on comparison with the golden standard (final clinical diagnosis determined by specialist groups). Specificity was calculated as True Negative / (True Negative + False Positive) Specificity: 100 x True negative(TN)/\[False positive(FP) + True negative(TN)\] (%)
次要结局
未报告次要终点