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Sonazoid Enhanced Liver Cancer Trial for Early Detection

Primary Purpose

Hepatocellular Carcinoma, Liver Cirrhosis, Hepatitis B

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
CE-US (Sonazoid™)
B-mode US
Sponsored by
Kindai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Sonazoid, Early detection, Hepatocellular carcinoma, Liver cirrhosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kinki University School of Medicine, Department of Gastroenterology and HepatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group of CE-US

Group of B-mode US

Arm Description

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

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

Outcomes

Primary Outcome Measures

Size of HCC which is detected first

Secondary Outcome Measures

Time to detection of HCC
The improvement of prognosis of patients who are diagnosed in this study

Full Information

First Posted
January 14, 2009
Last Updated
December 29, 2010
Sponsor
Kindai University
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1. Study Identification

Unique Protocol Identification Number
NCT00822991
Brief Title
Sonazoid Enhanced Liver Cancer Trial for Early Detection
Official Title
Sonazoid Enhanced Liver Cancer Trial for Early Detection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kindai University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Liver Cirrhosis, Hepatitis B, Hepatitis C
Keywords
Sonazoid, Early detection, Hepatocellular carcinoma, Liver cirrhosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group of CE-US
Arm Type
Active Comparator
Arm Description
screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
Arm Title
Group of B-mode US
Arm Type
Active Comparator
Arm Description
screening by conventional B-mode US every 3-5 months
Intervention Type
Device
Intervention Name(s)
CE-US (Sonazoid™)
Other Intervention Name(s)
Sonazoid Group
Intervention Description
screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
Intervention Type
Device
Intervention Name(s)
B-mode US
Other Intervention Name(s)
B-mode Group
Intervention Description
screening by conventional B-mode US every 3-5 months
Primary Outcome Measure Information:
Title
Size of HCC which is detected first
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Time to detection of HCC
Time Frame
10 years
Title
The improvement of prognosis of patients who are diagnosed in this study
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 20 HBV or HCV related liver cirrhosis No history of HCC 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 Inpatient or outpatient Patients who signed a written informed consent form Exclusion Criteria: History of hypersensitivity to egg yolk Pregnant or lactating women and women who may be pregnant Severe liver dysfunction(AST, ALT,or BIL level >10ULN Associated with HCC Patients receiving interferon Age under 20 Judged by investigator not to be appropriate for inclusion in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masatoshi Kudo, professor
Phone
+81-72-366-0221
Ext
3149
Email
m-kudo@med.kindai.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Kazuomi Ueshima, lecturer
Phone
+81-72-366-0221
Ext
3525
Email
kaz-ues@med.kindai.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masatoshi Kudo, professor
Organizational Affiliation
Kindai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kinki University School of Medicine, Department of Gastroenterology and Hepatology
City
Osaka-Sayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masatoshi Kudo, professor
Phone
+81-72-366-0221
Ext
3149
Email
m-kudo@med.kindai.ac.jp
First Name & Middle Initial & Last Name & Degree
Kazuomi Ueshima, lecturer
Phone
+81-72-366-0221
Ext
3525
Email
kaz-ues@med.kindai.ac.jp

12. IPD Sharing Statement

Citations:
PubMed Identifier
21301463
Citation
Kudo M, Hatanaka K, Kumada T, Toyoda H, Tada T. Double-contrast ultrasound: a novel surveillance tool for hepatocellular carcinoma. Am J Gastroenterol. 2011 Feb;106(2):368-70. doi: 10.1038/ajg.2010.432. No abstract available.
Results Reference
derived

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Sonazoid Enhanced Liver Cancer Trial for Early Detection

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