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临床试验/CTRI/2026/01/101817
CTRI/2026/01/101817尚未招募不适用

Development and validation of Artificial Intelligence (AI) models for prediction of glioma and meningioma recurrence using preoperative MRI – A Multicenter study

Indian Council of Medical Research2 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2026年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
380
试验地点
2
主要终点
Phase I:

研究概览

简要总结

The study aims to develop and validate machine learning (ML) and deep learning (DL) models for predicting the recurrence of glioma and meningioma using preoperative magnetic resonance imaging (MRI).

In the initial phase, retrospective MRI data from 300 patients (150 with glioma and 150 with meningioma) will be used to train ML and DL models based on documented recurrence outcomes.

Subsequently, the developed AI models will undergo prospective validation using preoperative MRI scans, with reference to postoperative MRI findings to confirm recurrence status.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Phase I (Retrospective) Inclusion criteria:
  • •Pre- and post-operative MRI Brain Images of the patients diagnosed with meningioma / Gliomas Phase II (Prospective) Inclusion criteria:
  • •Post operative cases referred for MRI Brain diagnosed with meningioma / Gliomas with available preoperative images.

排除标准

  • •Phase I (Retrospective) Exclusion criteria:
  • •Patients who had incomplete MRI Brain imaging data
  • •Suboptimal MRI image quality Phase II (Prospective) Exclusion criteria:
  • •Suboptimal MRI image quality.

结局指标

主要结局

Phase I:

时间窗: Phase I: (Retrospective) | 1. Preoperative MRI scan | 2. Post Operative MRI scan to check for the recurrence status | Phase II: | 1. Preoperative MRI | 2. Post Operative MRI scan to check for the recurrence status

The accuracy of Machine Learning (ML) and Deep Learning (DL) models for predicting glioma and meningioma recurrence using preoperative MRI with combined clinical and radiomic features.

时间窗: Phase I: (Retrospective) | 1. Preoperative MRI scan | 2. Post Operative MRI scan to check for the recurrence status | Phase II: | 1. Preoperative MRI | 2. Post Operative MRI scan to check for the recurrence status

Phase II:

时间窗: Phase I: (Retrospective) | 1. Preoperative MRI scan | 2. Post Operative MRI scan to check for the recurrence status | Phase II: | 1. Preoperative MRI | 2. Post Operative MRI scan to check for the recurrence status

Validation of the developed models

时间窗: Phase I: (Retrospective) | 1. Preoperative MRI scan | 2. Post Operative MRI scan to check for the recurrence status | Phase II: | 1. Preoperative MRI | 2. Post Operative MRI scan to check for the recurrence status

Development of explainable AI models

时间窗: Phase I: (Retrospective) | 1. Preoperative MRI scan | 2. Post Operative MRI scan to check for the recurrence status | Phase II: | 1. Preoperative MRI | 2. Post Operative MRI scan to check for the recurrence status

次要结局

  • Radiomic characterization of tumors(1. Preoperative MRI Scan)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Rajagopal Kadavigere Venkatachalaiah

Manipal Academy of Higher Education

研究点 (2)

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