跳至主要内容
临床试验/NCT05170282
NCT05170282Unknown不适用

Deep Learning Magnetic Resonance Imaging Radiomics for Diagnostic Value of Hepatic Tumors in Infants

West China Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
The diagnostic accuracy of infantile liver tumors with deep learning algorithm

研究概览

简要总结

Hepatic tumors in the perinatal period are associated with significant morbidity and mortality in affected patients. The conventional diagnostic tool, such as alpha-fetoprotein (AFP) shows limited value in diagnosis of infantile hepatic tumors. This retrospective-prospective study is aimed to evaluate the diagnostic efficiency of the deep learning system through analysis of magnetic resonance imaging (MRI) images before initial treatment.

详细描述

Hepatic tumors seldom occur in the perinatal period. They comprise approximately 5% of the total neoplasms of various types occurring in the fetus and neonate. Infantile hemangioendothelioma is the leading primary hepatic tumor followed by hepatoblastoma. It should be mentioned that alpha-fetoprotein (AFP) is highly elevated during the first several months after birth even in normal infants, thus the diagnostic value of AFP is limited for infantile patients with hepatic tumors. This study is a retrospective-prospective design by West China Hospital, Sichuan University, including clinical data and radiological images. A retrospective database was enrolled for patients with definite histological diagnosis and available magnetic resonance imaging (MRI) images from June 2010 and December 2020. The investigators have constructed a deep learning radiomics diagnostic model on this retrospective cohort and validated it internally. A prospective cohort would recruit infantile patients diagnosed as liver tumor since January 2021. The proposed deep learning model would also be validated in this prospective cohort externally. The established model would be able to assist diagnosis for hepatic tumor in infants.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
0 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age between newborn and 12 months
  • Receiving no treatment before diagnosis
  • With written informed consent

排除标准

  • Clinical data missing
  • Unavailable MRI images
  • Without written informed consent

结局指标

主要结局

The diagnostic accuracy of infantile liver tumors with deep learning algorithm

时间窗: 1 month

The diagnostic accuracy of infantile liver tumors with deep learning algorithm.

次要结局

  • The diagnostic sensitivity of infantile liver tumors with deep learning algorithm(1 month)
  • The diagnostic specificity of infantile liver tumors with deep learning algorithm(1 month)
  • The diagnostic positive predictive value of infantile liver tumors with deep learning algorithm(1 month)
  • The diagnostic negative predictive value of infantile liver tumors with deep learning algorithm(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuhan Yang

Doctor of Medicine

West China Hospital

研究点 (1)

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