Radiomics for Diagnosing Liver Diseases and Evaluating Progression

Study Overview
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Brief Summary
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Liver diseases are worldwide problems. liver fibrosis and hepatocellular carcinoma are mostly concerned by clinicians. Radiomcis can improve diagnosis accuracy and evaluate disease progression. Hence,investors try to combine radiomics and ultrasound images together in order to improve diagnosis performances of liver fibrosis, benign and malignant tumor and progression after liver ablations.

Detailed Description
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Liver diseases are worldwide problems including diffuse hepatitis disease and liver space occupying lesions. Hepatitis B virus infection is the most important one among difuse hepatitis disease. There are 240 million people infected with HBV globally, and more than one-third of these patients (approximately 93 million) live in China. For them, a precise estimation of the degree of liver fibrosis is important for estimation of prognosis, surveillance, and treatment decisions in patients with HBV infection. Hepatocellular carcinoma is usually detected in liver space occupying lesions and leading to third common death of cancer. Hence, precise diagnosis between benign and malignant tumor is of great significance. Many guidelines recommend ablation as first line treatment to small hepatocellular carcinoma, especially to those less than 1mm. Liver biopsy has been considered the gold standard for assessing liver diseases. However, it is limited because of sample errors, interobserver variability and many complications, such as pain, bleeding and even death. CT/MR are alternative ways with high cost and complications. Ultrasound was a first optional tool to diagnose liver disease. However, there are still some problems remained to solve:first, the diagnosis accuracy of liver fibrosis remained to be improved. Second,the diagnosis performances for distinguishing benign and malignant tumor were poor. Third, there were not objective way to assess progression after liver ablations. Radiomcis refers to the extraction and analysis of large amounts of image features from medical images. Previous studies showed that it can improve diagnosis accuracy and evaluating disease progression. Hence,we tried to combined radiomics and ultrasound images together in order to improve diagnosis performances of liver fibrosis, benign and malignant tumor and progression after liver ablations.

Official Title
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the Department of Medical Ultrasonics, Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Guangzhou, China.

Conditions
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Hepatitis B / Liver Space-occupying Lesions / Patients After Ablation

Intervention / Treatment
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* Diagnostic Test: radiomics


Participation Criteria
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Eligibility Criteria
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For chronic hepatitis patients to assess liver biopsy Inclusion Criteria: HBsAg positive or HBV-DNA detected agreed to undergo liver biopsy agreed to participated in our study Exclusion Criteria: combined with other liver disease(eg. HAV/HCV/HDV,alcoholic liver disease) combined with HIV combined with malignant liver space occupying lesions liver transplantation pregnant the sample size of liver biopsy could not demand: length lower than 15mm, portal areas less than 6. For patients classified between benign and malignant tumor Inclusion Criteria: patients diagnosed with liver space occupying lesions with histology results of liver space occupying lesions. agreed to participate in our study and signed informed consent. Exclusion Criteria: ultrasound images cant meet the demand for analysis without histology results For patients to estimate progression after ablation Inclusion Criteria: patients diagnosed with hepatocellular carcinoma; patients treated with ablation; patients performed the contrast-enhanced ultrasonography before ablation; patients who treated with transcatheter arterial chemoembolization (TACE) performed the contrast-enhanced ultrasonography performed before TACE; Exclusion Criteria: patients with lack of US digital imaging data loss to follow-up
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic hepatitis B patients<br>ultrasound and radiomics | Diagnostic Test: radiomics<br> <br> |
| patients with liver space occupying lesions<br>ultrasound and radiomics | Diagnostic Test: radiomics<br> <br> |
| patients undergo ablation<br>ablation, ultrasound and radiomics | Diagnostic Test: radiomics<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver fibrosis | the degree of liver fibrosis | 1 year | 
| benign or malignance | the malignance of liver space occupying lesions | 5 years | 
| The incidence of recurrence | the incidence of liver cancer recurrence after ablation | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnosis performance, hepatocellular carcinoma, liver fibrosis, progression