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Trial Title:
Sonazoid Enhanced Liver Cancer Trial for Early Detection
NCT ID:
NCT00822991
Condition:
Hepatocellular Carcinoma
Liver Cirrhosis
Hepatitis B
Hepatitis C
Conditions: Official terms:
Hepatitis A
Hepatitis C
Hepatitis B
Carcinoma, Hepatocellular
Liver Neoplasms
Hepatitis
Liver Cirrhosis
Fibrosis
Conditions: Keywords:
Sonazoid
Early detection
Hepatocellular carcinoma
Liver cirrhosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
CE-US (Sonazoid™)
Description:
screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
Arm group label:
Group of CE-US
Other name:
Sonazoid Group
Intervention type:
Device
Intervention name:
B-mode US
Description:
screening by conventional B-mode US every 3-5 months
Arm group label:
Group of B-mode US
Other name:
B-mode Group
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:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kinki University School of Medicine, Department of Gastroenterology and Hepatology
Address:
City:
Osaka-Sayama
Zip:
589-8511
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Masatoshi Kudo, professor
Phone:
+81-72-366-0221
Phone ext:
3149
Email:
m-kudo@med.kindai.ac.jp
Contact backup:
Last name:
Kazuomi Ueshima, lecturer
Phone:
+81-72-366-0221
Phone ext:
3525
Email:
kaz-ues@med.kindai.ac.jp
Start date:
January 2009
Completion date:
December 2019
Lead sponsor:
Agency:
Kindai University
Agency class:
Other
Source:
Kindai University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00822991
