Sonazoid Enhanced Liver Cancer Trial for Early Detection

• Time to detection of HCC [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
• The improvement of prognosis of patients who are diagnosed in this study [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

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.

• Hepatocellular Carcinoma
• Liver Cirrhosis
• Hepatitis B
• Hepatitis C

• Device: CE-US (Sonazoid™)
  screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
  Other Name: Sonazoid Group
• Device: B-mode US
  screening by conventional B-mode US every 3-5 months
  Other Name: B-mode Group

• Active Comparator: Group of CE-US
  screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
  Intervention: Device: CE-US (Sonazoid™)
• Active Comparator: Group of B-mode US
  screening by conventional B-mode US every 3-5 months
  Intervention: Device: B-mode US

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