A Multi-center, Prospective, Self-Controlled Diagnostic Accuracy Comparative Studies of Artificial Intelligence Diagnostic System for Surgical Neuropathology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 141
- 主要终点
- Diagnostic Accuracy of Study Arms
研究概览
简要总结
This is a multi-center, prospective, self-controlled, diagnostic accuracy comparative study of Artificial Intelligence Diagnostic System for Surgical Neuropathology. The investigators will compare the diagnostic efficiency of Artificial Intelligence with that of practicing pathologists, and suppose that the diagnostic efficiency of artificial intelligence in prospective clinical data is no less than that of pathologists.
详细描述
In this study, 141 patients will be recruited. After being enrolled, the patients will accept surgery and specimens for pathological analysis will be taken according to the routine treatment process.
The histopathologic slides will then be digitized by a whole-slide scanner. The images will be reviewed by gold standard committee for evaluation of ground truth. And then be separately diagnosed by Artificial Intelligence Diagnostic System and practicing pathologists. So the investigators can compare the diagnostic efficiency of Artificial Intelligence with that of pathologists, thus understand the gap between artificial intelligence and actual clinical practice.
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
- Single (Outcomes Assessor)
盲法说明
The AI group, ordinary pathologists and gold standard group will not be informed of each other's results
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients or their guardians understand the research process, agree to use their data, and sign the informed consent form;
- •Aged >=18 years;
- •MRI shows intracranial spaceoccupying lesions;
- •The clinical diagnosis is glioma, metastasis or lymphoma thus requiring surgical treatment;
- •The patient is willing to accept the surgery.
排除标准
- •The patient has serious underlying diseases thus is not suitable for surgery;
- •After further clinical evaluation, surgical treatment was not the best choice;
- •The patient participate in clinical research of other drugs or devices;
- •The researchers believe that there are other factors that will make the patients unable to complete the study.
结局指标
主要结局
Diagnostic Accuracy of Study Arms
时间窗: 1 week after the last patient's diagnosis is completed
The number of correctly diagnosed participants by study arms divided by the total number of participants
次要结局
- Sensitivity and specificity of Study Arms(1 week after the last patient's diagnosis is completed)
- Spearman Coefficient of Study Arms related to Gold Standard(1 week after the last patient's diagnosis is completed)
研究者
Jinsong Wu
Chief Physician of Neurosurgery Department, Vice-director of Neurosurgery Institute, Member of Ethics Committee, Clinical Professor of Surgery
Huashan Hospital