Sonazoid Enhanced Liver Cancer Trial for Early Detection

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00822991

Enrollment

760

Registered

2009-01-15

Start date

2009-01-31

Completion date

2019-12-31

Last updated

2010-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Hepatitis C, Hepatocellular Carcinoma, Liver Cirrhosis

Keywords

Sonazoid, Early detection, Hepatocellular carcinoma, Liver cirrhosis

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.

Interventions

DEVICECE-US (Sonazoid™)

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

DEVICEB-mode US

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Size of HCC which is detected first	10 years

Secondary

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

Countries

Japan

Contacts

Primary ContactMasatoshi Kudo, professor

m-kudo@med.kindai.ac.jp+81-72-366-0221

Backup ContactKazuomi Ueshima, lecturer

kaz-ues@med.kindai.ac.jp+81-72-366-0221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026