The Clinical Trial 01 to Evaluate the Effectiveness of MRI-based Computer Aided Diagnosis Software (V1) for Glioma Segmentation, Gene Prediction and Tumor Grading
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mingge LLC
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Accuracy rate
研究概览
简要总结
The goal of this multi-center clinical trial is to evaluate the effectiveness of MRI-based computer-aided diagnosis software (V1) for glioma segmentation, gene prediction, and tumor grading. Machine learning methods such as high-precision tumor segmentation and classification and discrimination modeling can further optimize the non-invasive molecular diagnosis and prognosis prediction. The main question it aims to answer is whether the software can predict the molecular type and the prognosis quickly and correctly. The results will be compared with the real-world clinical data double-blindly. Finally, form a set of user-friendly automatic glioma diagnosis and treatment systems for clinics.
详细描述
BACKGROUND:
The molecular type is crucial for surgical planning and post-operative treatment of glioma. MRI-based radiomics is an emerging technique that extracts unrevealed information including pathology, biomarkers, and genomics by using automated high-throughput extraction of a large number of quantitative features. With the help of artificial intelligence, MRI-based radiomics could be a promising noninvasive method to reveal molecular type by using a quantitative radiomics approach for glioma.
AIM:
MRI-based computer-aided diagnosis software (V1) is an MRI-based radiomics tool with machine learning methods such as high-precision tumor segmentation and classification and discrimination modeling that can further optimize the non-invasive molecular diagnosis and prognosis prediction. The main question it aims to answer is whether the software can predict the molecular type and the prognosis quickly and correctly.
PROCESS:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age front 18 to 70 years old (not including threshold), gender is not limited;
- •Preliminary diagnosis of glioma patients and patients who plan to undergo surgical treatment;
- •Preoperative cranial MRI (T1, T2, T2 Flair, T1 enhanced GE company magnetic resonance package), tumor pathological examination (H&E section, Kuoran Gene Company package), acceptable follow-up and brain MRI scan;
- •The patient himself voluntarily participated and signed the informed consent in writing.
排除标准
- •Patients who only underwent biopsy rather than surgical tumor resection;
- •Postoperative pathologically confirmed non-glioma patients;
- •Patients with multiple glioma metastases or multiple gliomas;
- •Patients who died of complications in the early postoperative period;
- •The researcher believes that this researcher should not be included.
结局指标
主要结局
Accuracy rate
时间窗: end of the study (one year after the surgery of the last participants).
describing the number of correct cases predicted by the software as a proportion of the total participants. The accuracy rate has a value between 0 and 1, with higher values indicating a more reliable tool.
次要结局
未报告次要终点