CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 400 enrolled
Drug / intervention
Video acquisitionother
Likely dose
Not stated in record
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Search/NCT04802954
NCT04802954N/ACompleted

Risk Stratification of Hepatocarcinogenesis Using a Deep Learning Based Clinical, Biological and Ultrasound Model in High-risk Patients

IHU Strasbourg·interventional·Posted Mar 17, 2021·Updated Dec 18, 2024

In Brief

A clinical study evaluating Video acquisition for Hepatocellular Carcinoma and Chronic Liver Disease. Completed, enrolled 400 participants across 6 sites.

Detailed Summary

By 2030, hepatocellular carcinoma (HCC) will become the second leading cause of cancer-related death, accounting for more than one million deaths per year according to the World Health Organization. To this date, screening for hepatocellular carcinoma in France remains uniform for all patients, based solely on a liver ultrasound every 6 months. This strategy has three main limitations: lack of personalisation, low compliance, relatively poor performance of the ultrasound. Risk stratification models have been developed for chronic hepatitis C, alcoholic cirrhosis and non-alcoholic steatohepatitis (NASH) including clinical and biological parameters but no analysis of the liver parenchyma which is the physiopathological substrate of hepatocarcinogenesis. The advent of new artificial intelligence techniques could revolutionize the approach and lead to a personalised radiological screening strategy. Deep learning, a subclass of machine learning, is a popular area of research that can help humans performing certain tasks by automatically identifying new image features not defined by humans. The hypothesis of this study is that the non-tumor cirrhotic liver parenchyma is rich in structural information reflecting the severity of the hepatopathy, its carcinological risk and the process of hepatocarcinogenesis. Its analysis combined with clinical and biological data, which have already been studied to stratify the risk of hepatocarcinogenesis, will allow to define a very high-risk population, particularly in the context of Hepatitis C Virus (HCV) eradication and Hepatitis B Virus (HBV) control. Consequently, this study proposes to design prospectively a deep learning model for stratification of the risk of hepatocarcinogenesis by including clinical, biological and radiological ultrasound parameters.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 17, 2021
Enrollment StartSep 1, 2021
Primary CompletionFeb 14, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.3 years ago

Interventions

Video acquisitionother

One to three video acquisitions of 10 seconds will be carried out via the intercostal route. Data acquisition will be standardized according to a mandatory protocol and previously recorded in each ultrasound machine (cross shots, harmonic, filter, depth, focal length, mechanical index, etc.).