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Sonazoid Enhanced Liver Cancer Trial for Early Detection
Conditions
Hepatocellular Carcinoma - Liver Cirrhosis - Hepatitis B - Hepatitis C
Conditions: official terms
Carcinoma, Hepatocellular - Hepatitis - Hepatitis A - Liver Cirrhosis
Conditions: Keywords
Sonazoid, Early detection, Hepatocellular carcinoma, Liver cirrhosis
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: CE-US (Sonazoid™)
Type: Device
Name: B-mode US
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: 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
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
Location
Kinki University School of Medicine, Department of Gastroenterology and Hepatology
Osaka-Sayama, Osaka, Japan
Status: Recruiting
Contact: Masatoshi Kudo, professor - +81-72-366-0221 - m-kudo@med.kindai.ac.jp
Start Date
January 2009
Completion Date
December 2019
Sponsors
Japan Liver Oncology Group
Source
Japan Liver Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page