跳至主要内容
临床试验/NCT07608003
NCT07608003招募中不适用

Application of MRI-Based Artificial Intelligence Models for Preoperative Molecular Subtyping and Prognostic Assessment of Midline Gliomas: A Multicenter Prospective Clinical Study

Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年5月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1

研究概览

简要总结

A vision-language model using preoperative MRI and clinical variables has been developed to simultaneously predict three key molecular markers in midline gliomas: H3K27M, IDH, and 1p/19q. This prospective multicenter study will validate the model's accuracy in preoperative molecular subtyping and its value in prognostic assessment and clinical decision-making across multiple neurosurgical centers.

详细描述

This study aims to validate the clinical value of an MRI-based artificial intelligence model for personalized diagnosis and treatment in patients with midline gliomas. The model integrates preoperative MRI features with clinical variables (e.g., age, sex, and other relevant patient characteristics) to predict both molecular subtypes and patient prognosis.

Model workflow. The model takes as input tumor-containing slices from preoperative MRI sequences, along with patient age and sex. By recognizing information within the MRI sequences, the model outputs the predicted molecular diagnosis for the patient.

Primary objective. To evaluate the model's accuracy in preoperative molecular subtyping of midline gliomas (H3K27M, IDH, and 1p/19q status) by comparing its predictions with the gold standard of postoperative or post-biopsy pathology. Diagnostic performance will be assessed using sensitivity, specificity, accuracy, F1 score, and area under the receiver operating characteristic curve (AUC).

Secondary objective. To assess the model's prognostic capability by integrating imaging features with clinical variables to predict patient survival outcomes and treatment response. Prognostic performance will be evaluated using time-dependent AUC and calibration metrics.

Exploratory objective. To explore the model's added value in clinical decision-making, including its potential to guide preoperative treatment planning and risk stratification.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with diffuse gliomas were pathologically and molecularly diagnosed.
  • The clinical case data of all patients were complete.
  • Patients underwent preoperative MRI examination.

排除标准

  • The tumor is not located in the intracranial midline.
  • Cases in which MRI were incomplete or with significant noise and artifacts.

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xuan Gong

Associate Consultant

Xiangya Hospital of Central South University

研究点 (1)

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