Rapid Diagnosis of Molecular Biomarkers and Visualization of IDH Molecular Boundaries in Glioma Using Preoperative Magnetic Resonance Images, Intraoperative Ultrasound Signals and Intraoperative Ultrasound Images
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mingge LLC
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Accuracy rate, describing the number of correct people or correct regions predicted by the computer-aided algorithm as a proportion of the total sample.
研究概览
简要总结
The aim of this observational study is to enable rapid diagnosis of molecular biomarkers in patients during surgery by medical imaging and artificial intelligence models, to help clinicians with strategies to maximize safe resection of gliomas. The main questions it aims to answer are:
- To solve the current clinical shortcomings of intraoperative molecular diagnosis, which is time-consuming and complex, and enables rapid and automated molecular diagnosis of glioma, thus providing the possibility of personalized tumor resection plans.
- To implement a neuro-navigation platform that combines preoperative magnetic resonance images, intraoperative ultrasound signals and intraoperative ultrasound images to address real-time molecular boundary visualisation and molecular diagnosis for glioma, providing an approach to improve glioma treatment.
Participants will read an informed consent agreement before surgery and voluntarily decide whether or not to join the experimental group. they will undergo preoperative magnetic resonance imaging, intraoperative ultrasound, and postoperative genotype identification. Their imaging data, genotype data, clinical history data, and pathology data will be used for the experimental study. The data collection process will not interrupt the normal surgical process.
详细描述
BACKGROUND:
The extent of glioma resection is directly related to patient survival, and a combination of multiple imaging and molecular pathology imaging methods has been developed to achieve maximum safe resection. In this study, three types of data, preoperative magnetic resonance imaging, intraoperative ultrasound and molecular genotype, will be collected and combined to build an artificial intelligence imaging model to achieve maximum safe resection and prolong patient's life.
PLAN:
In order to achieve the goal of maximum safe resection, we plan to sequentially implement imaging-based molecular visualization techniques, and integrated guidance techniques through a combination of intraoperative ultrasound and preoperative magnetic resonance imaging, in order to address the two critical scientific issues of glioma molecular boundary visualization and intraoperative real-time molecular diagnosis. It can also help neurosurgeons to achieve complete glioma resection at the molecular level, maximizing patient survival time and providing another effective approach to improving glioma treatment.
PROCESS:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old
- •Tumor in non-functional areas of the cerebral hemisphere.
- •Preoperative diagnosis of glioma.
- •Undergo glioma removal surgery.
排除标准
- •Postoperative confirmation of non-glioma.
- •Magnetic resonance or ultrasound data not available.
结局指标
主要结局
Accuracy rate, describing the number of correct people or correct regions predicted by the computer-aided algorithm as a proportion of the total sample.
时间窗: End of study (24 weeks)
The accuracy rate has a value between 0 and 1, with higher values indicating a more reliable system.
次要结局
未报告次要终点