Sonazoid Enhanced Liver Cancer Trial for Early Detection

Kindai University

Status: Unknown

Conditions: Hepatitis C; Liver Cirrhosis; Hepatocellular Carcinoma; Hepatitis B

Treatments: Device: B-mode US; Device: CE-US (Sonazoid™)

Study type: Interventional

Funder types: Other

Identifiers

NCT00822991

UMIN000001612

JLOG08001

Details and patient eligibility

About

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.

Enrollment: 760 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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760 participants in 2 patient groups

Group of CE-US

Active Comparator group

Description:

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

Treatment:

Device: CE-US (Sonazoid™)

Group of B-mode US

Active Comparator group

Description:

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

Treatment:

Device: B-mode US