Sonazoid Enhanced Liver Cancer Trial for Early Detection

Not Applicable

• Conditions: Hepatitis C; Liver Cirrhosis; Hepatocellular Carcinoma; Hepatitis B
• Interventions: Device: CE-US (Sonazoid™); Device: B-mode US

• Registration Number: NCT00822991
• Lead Sponsor: Kindai University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Study First Posted: 2009-01-15
• Last Update Submitted: 2010-12-29
• Last Update Posted: 2010-12-30
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 760

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Size of HCC which is detected first	10 years

Secondary Outcome Measures

Name	Time	Method
Time to detection of HCC	10 years
The improvement of prognosis of patients who are diagnosed in this study	10 years

Trial Locations

Locations (1)

Kinki University School of Medicine, Department of Gastroenterology and Hepatology; 🇯🇵 Osaka-Sayama, Osaka, Japan