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临床试验/NCT03198975
NCT03198975Unknown不适用

Development of a Machine Learning-based Model for Preoperative Prediction of Microvascular Invasion in Hepatocellular Carcinoma

Ming Kuang1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年6月23日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Presence of microvascular invasion

研究概览

简要总结

Microvascular invasion (MVI) has been well demonstrated as an unfavorable prognostic factor for hepatocellular carcinoma (HCC), and patients with MVI have a high risk of tumor recurrence after curative hepatectomy. Currently, the diagnosis of MVI is determined on the postoperative histologic examination, which greatly limits its influence on preoperative decision making. Therefore, we constructed this prospective study to develop a machine learning-based model for preoperative prediction of MVI by extracting high-dimensional magnetic resonance (MR) image features.

详细描述

Histologically-diagnosed primary HCC after curative hepatectomy. The magnetic resonance image will be imported into the imaging management software (GE healthcare Analysis-Kit software),and the tumor lesions will manually delineated by two independent radiologists and then reconstruct into three-dimensional images for feature extraction. The radiomic textural features including grayscale histogram, transform matrix, wavelet transform and filter transformation are automatically extracted by the Analysis-Kit software.The high-throughput extracted features will be then selected by the univariate analysis, and a prediction model will be developed based on machine learning algorithm in a training set in which patients were collected from a retrospective study. And in the present study, an independent validation set will be collected and used to validate the prediction accuracy of the model.

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

  • •Asian patients aged 18~80 years old;
  • •HCC without macroscopic vascular invasion according to imaging findings;
  • •Child Pugh A-B stage;
  • •Receipt of preoperative Gd-EOB-DTPA enhanced MR imaging of the abdomen within one month before surgery;
  • •Histologically-diagnosed primary HCC after curative hepatectomy;

排除标准

  • •Combined hepatocellular-cholangiocarcinoma;
  • •With extra-hepatic metastasis or macrovascular invasion;
  • •With incomplete clinical and imaging data;
  • •Non-radical resection;

结局指标

主要结局

Presence of microvascular invasion

时间窗: Through patient enrollment completion ,an average of 2 years

Postoperative histologically confirmed microvascular invasion

次要结局

未报告次要终点

研究者

发起方
Ming Kuang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ming Kuang

Professor

Sun Yat-sen University

研究点 (1)

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