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临床试验/NCT06103175
NCT06103175进行中(未招募)不适用

Observational and Prospective Study of Hepatic Steatosis and Related Risk Factors Using Ultrasound and Artificial Intelligence

University of Bari1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
150
试验地点
1
主要终点
Magnetic Resonance scanning and fat percentage evaluation

研究概览

简要总结

Fatty liver is the most frequent chronic liver disease worldwide and ultrasonography is widely employed for diagnosis. The accuracy of this technique, however, is strongly operator-dependent. Few information is available, so far, on the possible use of algorithms based on Artificial Intelligence (AI) to ameliorate the diagnostic accuracy of ultrasonography in diagnosing fatty liver. This study showed that the use of AI is able to improve the diagnostic accuracy of ultrasonography in the diagnosis of fatty liver

详细描述

In recent years, ultrasound has taken on a predominant role in the evaluation of liver steatosis, as it is a non-invasive, non-irradiating method that is easily reproducible and inexpensive. Of particular effectiveness is the use of the hepatorenal index, evaluated as the intensity ratio (echogenicity) between the hepatic parenchyma and the renal cortical parenchyma. The main limitations of detecting the hepato-renal index during abdominal ultrasound, however, are operator dependence and the use of a relatively long time span to complete the sequence of operations and calculations required to determine the index itself. The use of Artificial Intelligence (AI) techniques for image analysis in the medical field is yielding excellent results. AI-based algorithms are increasingly a powerful tool that allows the physician to improve their performance in terms of speed and accuracy of clinical evaluations. Today, there is already evidence of the effectiveness of using AI on ultrasound images for clinical evaluations. The use of AI as an aid in diagnosing liver diseases through ultrasound is still under-researched. The hypothesis to be tested is the utility that AI can have in the evaluation, its general and specific uses in reducing calculation times of the hepatorenal index.

In this study, 134 patients were enrolled with no clinical suspicion of liver steatosis. All patients underwent abdominal ultrasonography (US) and magnetic resonance imaging fat fraction (MRI-PDFF), assumed as reference technique to evaluate the grade of steatosis. The hepatorenal index (US) was manually calculated (HRIM) by 4 skilled operators. An automatic hepatorenal index calculation (HRIA) was also obtained by an algorithm. The accuracy of HRIA to discriminate different grades of fatty liver was evaluated by Receiver operating characteristic (ROC) analysis using MRI-PDFF cut-offs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-70 years
  • MRI regardless of clinical indications,
  • written informed consent

排除标准

  • cirrhosis
  • hepatocellular carcinoma or any liver tumours,
  • absence of the right kidney
  • previous liver transplantation
  • large liver cysts or kidney cysts

结局指标

主要结局

Magnetic Resonance scanning and fat percentage evaluation

时间窗: 4 months

Proton Density Fat Fraction MRI scans (MRI-PDFF) to evaluate the liver fat percentage as the average value of percentage of fat evaluated for each liver segment

Hepato-renal index calculation

时间窗: 4 months

Calculation of the Hepatorenal Index manually and automatically using the AI-based algorithm.

次要结局

未报告次要终点

研究者

发起方
University of Bari
申办方类型
Other
责任方
Principal Investigator
主要研究者

piero portincasa

Professor, MD

University of Bari

研究点 (1)

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