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Prediction of Significant Liver Fibrosis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06509230
Acronym
PSLF
Enrollment
700
Registered
2024-07-19
Start date
2024-07-20
Completion date
2026-12-31
Last updated
2024-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Fibrosis

Keywords

Chronic hepatitis, Liver fibrosis, Artificial intelligence, Auxiliary diagnosis

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

East China University of Science and Technology
CollaboratorOTHER
Huang Haijun
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age of 18-60 years old 2. 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 3. Imaging showed no liver cancer

Exclusion criteria

1. There are contraindications for liver biopsy 2. Liver pathology did not meet the criteria

Design outcomes

Primary

MeasureTime frameDescription
Model development2024.6-2024.12Imaging (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

MeasureTime frameDescription
Build a multi-modal big data liver fibrosis early warning cloud platform system2025.1-2025.12We 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

MeasureTime frameDescription
Evaluation Multi-modal big data liver fibrosis warning platform system effectiveness2026.1-2026.12To 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

Countries

China

Contacts

Primary ContactHaijun Huang
huanghaijun0826@163.com13758186635

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026