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临床试验/NCT06760494
NCT06760494已完成不适用

Prediction of Microvascular Invasion in HCC Using Spatiotemporal Radiomics of Contrast-enhanced Ultrasound: a Deep Learning Model With Transcriptomics Correlation

Chinese PLA General Hospital2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2023年11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
250
试验地点
2
主要终点
area under operating characteristic curves (AUC)

研究概览

简要总结

An artificial intelligence (AI) model to predict MVI of HCC using contrast-enhanced ultrasound was constructed. This model also has biological explainability. The investigators named it as MAPUSE (MVI AI prediction via contrast-enhanced ultrasound with explainability).

The goal of MAPUSE study is to prospectively test the performance of MAPUSE model on MVI prediction and its biological correlation in different geographical areas of China.

详细描述

The presence of microvascular invasion (MVI) in hepatocellular carcinoma (HCC) is a critical prognostic indicator, but its preoperative diagnosis remains challenging. Contrast-enhanced ultrasound (CEUS), with its dynamic microvascular imaging capability, holds promise in prediction of MVI.

The investigators constructed an artificial intelligence (AI) model to predict MVI using contrast-enhanced ultrasound. This model also has biological explainability. We named it as MAPUSE (MVI AI prediction via contrast-enhanced ultrasound with explainability).

The goal of MAPUSE study is to prospectively test the performance of MAPUSE model on MVI prediction and its biological correlation in different geographical areas of China.

The performance of MAPUSE is to be tested in two prospective testing cohorts from two centers in southern and northern China. Before surgery, patient CEUS videos will be collected and analysed by MAPUSE model to generate an MVI risk score. According to the postoperative pathological diagnosis of MVI (golden criterion), the result of MAPUSE will be evaluated. Parameters include area under curve (AUC), accuracy (ACC), sensitivity, specificity and F1-score.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age >18 years old.
  • •The HCC diagnosis and the presence of MVI were confirmed by surgical pathology.
  • •Complete and clear CEUS videos obtained within two weeks preoperatively.

排除标准

  • •Unqualified CEUS images.
  • •Missing surgical pathological diagnosis.
  • •Lesions underwent local treatments.
  • •Non-HCC diagnosis

结局指标

主要结局

area under operating characteristic curves (AUC)

时间窗: From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively)

the area under operating characteristic curves (AUC) to evaluate the performance of MAPUSE model in predicting MVI in HCC patients

次要结局

  • ACC (accuracy)(From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively))
  • Specificity(From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively))
  • Sensitivity(From preoperative enrollment to the postoperative confirmation of pathological diagnosis (7-15 days postopertively))

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ping Liang

Professor

Chinese PLA General Hospital

研究点 (2)

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