Sonazoid Enhanced Liver Cancer Trial for Early Detection

December 29, 2010 updated by: Japan Liver Oncology Group
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

760

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Osaka-Sayama, Osaka, Japan, 589-8511
        • Recruiting
        • Kinki University School of Medicine, Department of Gastroenterology and Hepatology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group of CE-US
screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
Device: CE-US (Sonazoid™)
screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
Other Names:
  • Sonazoid Group
Active Comparator: Group of B-mode US
screening by conventional B-mode US every 3-5 months
Device: B-mode US
screening by conventional B-mode US every 3-5 months
Other Names:
  • B-mode Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Size of HCC which is detected first
Time Frame: 10 years
10 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Liver Oncology Group

Investigators

  • Principal Investigator: Masatoshi Kudo, professor, Japan Liver Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (Estimate)

January 15, 2009

Study Record Updates

Last Update Posted (Estimate)

December 30, 2010

Last Update Submitted That Met QC Criteria

December 29, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLOG08001
  • UMIN000001612

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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