Clinical trial NCT03221049: Radiomics for Diagnosing Liver Diseases and Evaluating Progression
Official title: the Department of Medical Ultrasonics, Third Affiliated Hospital of Sun Yat-Sen University, 600 Tianhe Road, Guangzhou, China.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B / Liver Space-occupying Lesions / Patients After Ablation
Keywords: diagnosis performance
hepatocellular carcinoma
liver fibrosis
progression
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic hepatitis B patients /patients with liver space occupying lesions / patients after ablation

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.

Eligibility criteria: 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

Primary outcomes:
measure: liver fibrosis
timeFrame: 1 year
measure: benign or malignance
timeFrame: 5 years
measure: The incidence of recurrence
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
state: Guangdong
Study officials:
affiliation: The department of Ultrasound, the third affiliated hospital of Sun Yat-sen University
name: rongqin zheng, doctor
role: PRINCIPAL_INVESTIGATOR
References: