Radiomics for Diagnosing Liver Diseases and Evaluating Progression

NCT ID: NCT03221049

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2022-12-31

Brief Summary

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

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

chronic hepatitis B patients

ultrasound and radiomics

radiomics

Intervention Type: DIAGNOSTIC_TEST

patients with liver space occupying lesions

ultrasound and radiomics

radiomics

Intervention Type: DIAGNOSTIC_TEST

patients undergo ablation

ablation, ultrasound and radiomics

radiomics

Intervention Type: DIAGNOSTIC_TEST

Interventions

radiomics

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• HBsAg positive or HBV-DNA detected
• agreed to undergo liver biopsy
• agreed to participated in our study

• 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.

• 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

• 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

• ultrasound images cant meet the demand for analysis
• without histology results

For patients to estimate progression after ablation

• patients with lack of US digital imaging data
• loss to follow-up

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Rongqin Zheng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rongqin zheng, doctor

Role: PRINCIPAL_INVESTIGATOR

The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University

Locations

The department of Ultrasound, the third affiliated hospital of Sun Yat-son University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

sysu2017

Identifier Type: -

Identifier Source: org_study_id