An Open Label, Single-Center and Random-Selection Retrospective Pivotal Study of Clinical Decision Support System for Brain Metastasis Using Brain MR Images
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Heuron Inc.
- 入组人数
- 558
- 试验地点
- 1
- 主要终点
- Sensitivity and false positive rates of BT-M01
研究概览
简要总结
BT-M01 is a software that has been pre-learned based on a brain metastasis detection model using brain MR images, and clinical decision support system for brain metastasis by automatically analyzing brain MR images by assisting the medical team.
The specific aims of this study are to evaluate efficacy of BT-M01 for brain metastasis compared to the sensitivity and false positive rates of radiologists group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 19 years old
- •Brain MR acquired
- •Positive group: A patient diagnosed with brain metastasis after a brain MR
- •Negative group: A normal person or a patient not diagnosed with brain metastasis after a brain MR
排除标准
- •Poor or incomplete brain MR image quality
- •A patient with other pathological lesion in brain
- •A patients with a history of primary brain tumors
研究组 & 干预措施
Positive group
A patient diagnosed with brain metastasis after a brain MR
干预措施: BT-M01 (Device)
Negative group
A normal person or a patient not diagnosed with brain metastasis after a brain MR
干预措施: BT-M01 (Device)
结局指标
主要结局
Sensitivity and false positive rates of BT-M01
时间窗: Within 4 weeks after enrollment
Sensitivity and false positive rates of BT-M01 in detection of brain metastasis based on golden standards
次要结局
- Positive predictive values of BT-M01(Within 4 weeks after enrollment)
- Sensitivity and Positive predictive values of BT-M01 by primary cancer(Within 4 weeks after enrollment)
- Dice coefficient of BT-M01(Within 4 weeks after enrollment)