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临床试验/NCT06336499
NCT06336499已完成不适用

Risk Stratification of Orbital Tumors Based on MRl and Artificial Intelligence

Beijing Tongren Hospital0 个研究点目标入组 600 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
主要终点
The area under the curve of Receiver Operating Characteristic of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and levels of Ki-67 expression in malignant ones.

研究概览

简要总结

Orbital tumors can be categorized into benign and malignant tumors, and there are significant variations in their biological behavior, treatment, and prognosis. This study aims to enhance the accurate diagnosis and risk stratification of orbital tumors using artificial intelligence (AI) technology and multiparameter magnetic resonance imaging (MRI) data. It further explores the intrinsic relationship between MRI and the differential diagnosis of benign and malignant orbital tumors, as well as the pathological subtypes of malignant tumors and Ki-67 expression levels. This research aims to aid in guiding personalized diagnosis and treatment decision-making for patients with orbital tumors while promoting the practical application and incorporation of AI technology.

详细描述

Although orbital tumors are less common than other eye-related diseases, they can be extremely detrimental to patients. Not only can they cause physical disfigurement, but they can also lead to functional impairments such as diminished vision and restricted eye movement. Orbital tumors can be categorized as either benign or malignant, and there are significant disparities in their biological behavior, treatment approaches, outcomes, and prognosis, which complicates the processes of differential diagnosis and treatment selection. For malignant lesions, the treatment plans and prognosis of patients vary due to the different pathological types and stages. Hence, there is a pressing clinical necessity to devise accurate diagnostic methods for orbital tumors. Multiparametric magnetic resonance imaging (mp-MRI) currently stands as the leading non-invasive imaging technique for diagnosing orbital tumors. This study is centered on precise diagnosis of orbital tumor risk stratification, utilizing artificial intelligence algorithm technology to explore the inherent connection between MRI images and the distinguishing diagnosis of benign and malignant orbital tumors, histological types and Ki-67 expression levels of malignant tumors. It aims to integrate clinical information and quantitative MRI features to construct prediction models, aid in guiding individual diagnosis and treatment decisions for patients with orbital tumors and facilitate the application and advancement of artificial intelligence technology. Specifically, the research objectives are outlined as follows:

  1. Establishing a deep learning-based automatic segmentation model for orbital tumors using a multi-sequence MRI dataset from multiple centers, thereby reducing the time required for manual delineation and proving beneficial for subsequent analysis.
  2. Developing a model for identifying malignant and benign orbital tumors using multiple machine learning algorithms combined with multi-sequence MRI dataset, with the aim of providing more precise information for distinguishing between these two entities.
  3. Constructing robust diagnostic models using machine learning or deep learning approaches with quantitative multi-sequence MRI features to identify the histological type and Ki-67 expression levels of malignant orbital tumors, with the purpose of enhancing detection rates and accuracy, thereby achieving risk stratification for patients with malignant orbital tumors.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients with orbital tumors who underwent pre-operative multiparametricMRl (mp-MRl) at Beijing Tongren Hospital from 2015 to 2022.

排除标准

  • The patients without pre-operative multiparametric MRl (mp-MRl) or clear pathological diagnosis.

结局指标

主要结局

The area under the curve of Receiver Operating Characteristic of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and levels of Ki-67 expression in malignant ones.

时间窗: Pre-operation

The area under the ROC curve is calculated by integrating the ROC curve, which plots Sensitivity against 1 - Specificity.

次要结局

  • Accuracy of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors.(Pre-operation)
  • The area under the Precision-Recall curve of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors.(Pre-operation)
  • Sensitivity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors.(Pre-operation)
  • Specificity of the diagnostic models for the differential diagnosis of malignant and benign orbital tumors, high and low grades of histological types, and high and low levels of Ki-67 expression in malignant orbital tumors.(Pre-operation)

研究者

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Sponsor

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