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NCT Number: NCT06509230

Prediction of Significant Liver Fibrosis

The deep learning method based on convolutional neural network (CNN) was used to extract the relevant features of liver fibrosis classification from the multi-modal information of digital pathological sections, clinical parameters and biomarkers of a large number of existing cases of liver puncture, and the U-Net architecture of CNN was used to segment and extract the features of clinical medical images.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haijun Huang

Hangzhou, Zhejiang, 310014, China

Location status: Recruiting

Location contact

Haijun Huang

CONTACT

[email protected]

13758186635

About this study

Patients with chronic hepatitis B underwent B-ultrasound-guided liver biopsy, and were divided into mild liver fibrosis group (fibrosis grade 0-1, S1), significant liver fibrosis group (fibrosis grade 2, S2), advanced liver fibrosis group and early cirrhosis group (fibrosis grade 3-4, S3-4) according to the pathological results.In this study, 200 patients with different degrees of liver fibrosis and 200 normal volunteers were collected from 2018 to 2022, and their clinical biochemical data, imaging data and peripheral blood samples were collected.The pathological microenvironment characteristics, imaging characteristics, clinical parameter characteristics and other data of patients were extracted, and the distillation learning method based on teacher-student model was adopted to develop and construct a multi-modal big data analysis model for accurate grading of liver fibrosis, so as to achieve a non-invasive intelligent grading diagnosis system for liver fibrosis.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of 18-60 years old
  • The diagnosis of chronic hepatitis B is in line with the diagnostic criteria of China's 2019 Chronic Hepatitis B Prevention and Treatment Guidelines, and the diagnosis of non-alcoholic fatty liver is in line with the Asian Pacific Hepatology Association guidelines
  • Imaging showed no liver cancer

Exclusion criteria

  • There are contraindications for liver biopsy
  • Liver pathology did not meet the criteria

Treatment and study plan

Primary outcomes

  1. Model development

    Time frame: 2024.6-2024.12

    Imaging (such as CT scan, MRI, X-ray, etc.) features and clinical parameters of patients were extracted, including population baseline characteristics (such as age, gender, comorbiditions, etc.), blood biochemical indicators (such as blood glucose, lipids, liver function indicators, etc.), and blood cytology indicators (such as white blood cell count, red blood cell count, etc.). Completed case selection and cohort establishment, multi-modal feature extraction and model development

Secondary outcomes

  1. Build a multi-modal big data liver fibrosis early warning cloud platform system

    Time frame: 2025.1-2025.12

    We intend to design a cloud platform with data storage, processing and analysis components.Select the appropriate technology stack to ensure that the platform has the ability to handle large-scale data, and has good scalability and performance.The previously built multimodal liver fibrosis precision typing model was then embedded into the platform, ensuring that the model could handle a variety of data types and integrate seamlessly with other components of the platform.At the same time, the stream processing technology is used to integrate the real-time monitoring and analysis function of the platform, so as to make rapid prediction and classification of the newly acquired liver fibrosis case data.The accuracy and stability of the model were further verified in the multi-center clinical data, and the multi-modal big data liver fibrosis early warning cloud platform system was built

Other outcomes

  1. Evaluation Multi-modal big data liver fibrosis warning platform system effectiveness

    Time frame: 2026.1-2026.12

    To test the effectiveness of the multi-modal big data liver fibrosis warning platform system in a real multi-center clinical environment. We will also explore the possibility of using the platform for long-term follow-up of patients, remote testing of patients and regular assessment of disease progression

Study contacts

Contact information is provided by the study sponsor or research team.

Haijun Huang

CONTACT

[email protected]

13758186635

Sponsors and collaborators

Lead sponsor

Huang Haijun

Other

Collaborators

  • East China University of Science and Technology

Registry information

Official study title

Multimodal Digital Image Fusion Technology Based on Deep Learning to Predict Significant Liver Fibrosis and Its Application in Multi-center Research

Acronym: PSLF

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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