跳至主要内容
临床试验/NCT05137301
NCT05137301招募中不适用

Performance of the Diagnostic Value of Bone Age Assessment Software Based on Deep Learning in Chinese Children

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
bone age

研究概览

简要总结

High accuracy and precision bone age assessment is very important for the diagnosis and treatment monitoring of various pediatric diseases. The commonly used bone age assessment methods include GP atlas, TW3 score and Zhonghua 05. GP method is to compare wrist X-ray films with atlas reference X-ray films. Its main disadvantages are strong subjectivity and long atlas standard interval. Different from GP method, TW3 method is to grade and score each bone, add each epiphyseal score to calculate the total score of bone maturity, and obtain the corresponding final bone age value. Although TW3 scoring method is relatively accurate, it is complex and time-consuming, and there is great variability among evaluators. In order to evaluate bone age more efficiently and accurately, a method based on computer image automatic recognition technology can help to overcome these problems.

In this study, 1000 children aged 1-18 in 5 hospitals are selected as the research objects. After taking bone age films with bone age instrument, the film reading results and evaluation time of AI Group, artificial group and standard group are recorded. One month later, the artificial group re-analyzes 1000 films with the assistance of AI system, and the evaluation time is recorded. Finally, the accuracy and time difference of artificial group, AI Group, artificial combined AI Group and standard group are compared.

The purpose of this study is to use the most advanced artificial intelligence deep learning bone age evaluation software to explore the value of bone age instrument to improve the accuracy and diagnostic efficiency of bone age evaluation by pediatricians.

详细描述

  1. Study subjects: Radiographs of the left wrist of 1000 children aged 1-18 years who underwent bone age measurement at 5 hospitals were selected
  2. Research methods:

2.1 general information: name, gender, actual age, height, weight, BMI, race, disease type 2.2 main instrument: artificial intelligence X-ray bone age instrument 2.3 scanning scheme: Left posterior and anterior radiographs 2.4 bone age evaluation method and group 2.4.1 the standard group:Tw3-RUS and TW3-CARPAL were used to evaluate the left hand bone age tablets by the 5 pediatric doctors designated in the TW3 system training. There was no time limit for reading the tablets. The mean value of the evaluation results of the 5 doctors was taken as the final reference standard.

2.4.2 Grouping of bone age assessment ① artificial group (5 assessors assess bone age separately) ② AI Group③ artificial + AI Group (artificial Group assesses bone age with the assistance of AI intelligent software assessment) After taking bone age films with bone age instrument, the film reading results and evaluation time of AI Group, artificial group and standard group are recorded. One month later, the artificial group re-analyzes 1000 films with the assistance of AI system, and the evaluation time is recorded. Finally, the accuracy and time difference of artificial group, AI Group, artificial combined AI Group and standard group are compared.

研究设计

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

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Children aged 1 to 18 years.
  • •Clinical diagnosis of requiring bone age examination.

排除标准

  • •There are obstructions or implants in the wrist bone, such as metal.
  • •Poor resolution, which affects the observation of bone characteristics.
  • •Poor shooting position of the wrist due to various reasons.

结局指标

主要结局

bone age

时间窗: one month

The mean absolute error (MAE) and root mean square error (RSME) between the evaluation bone age results of different groups

次要结局

未报告次要终点

研究者

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

Xiaoping Luo

Director of Pediatrics

Tongji Hospital

研究点 (1)

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