Sonazoid Enhanced Liver Cancer Trial for Early Detection

Kindai University760 enrolled

Overview

The aim of this study is to prove usefulness of contrast-enhanced ultrasound (CE-US) using Sonazoid (TM) in the early detection of HCC as compared with conventional B-mode ultrasound (B-mode US) for hepatitis virus related cirrhosis, who are defined as super high-risk patients for hepatocarcinogenesis,Furthermore, to analyze whether early detection of HCC by CE-US has a survival benefit than that by B-mode US.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

760

Conditions

Hepatocellular Carcinoma Liver Cirrhosis Hepatitis B Hepatitis C

Interventions

CE-US (Sonazoid™)DEVICE

screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months

B-mode USDEVICE

screening by conventional B-mode US every 3-5 months

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age over 20 2. HBV or HCV related liver cirrhosis 3. No history of HCC 4. Diagnosed as liver cirrhosis histologically or clinically Histologically confirmed by liver biopsy Confirmed by formula of diagnosing cirrhosis Radiological finding Finding of portal hypertension Platelet\<130,000 5. Inpatient or outpatient 6. Patients who signed a written informed consent form Exclusion Criteria: 1. History of hypersensitivity to egg yolk 2. Pregnant or lactating women and women who may be pregnant 3. Severe liver dysfunction(AST, ALT,or BIL level \>10ULN 4. Associated with HCC 5. Patients receiving interferon 6. Age under 20 7. Judged by investigator not to be appropriate for inclusion in this study

Locations (1)

Kinki University School of Medicine, Department of Gastroenterology and Hepatology

Ōsaka-sayama, Osaka, Japan

RECRUITING

Outcomes

Primary Outcomes

Size of HCC which is detected first

Time frame: 10 years

Secondary Outcomes

Time to detection of HCC

Time frame: 10 years

The improvement of prognosis of patients who are diagnosed in this study

Time frame: 10 years

Central Contacts

Masatoshi Kudo, professor

CONTACT

+81-72-366-0221 m-kudo@med.kindai.ac.jp

Kazuomi Ueshima, lecturer

CONTACT

+81-72-366-0221 kaz-ues@med.kindai.ac.jp

Data from ClinicalTrials.gov

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