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Sonazoid Enhanced Liver Cancer Trial for Early Detection

This study is currently recruiting participants.
Verified January 2009 by Japan Liver Oncology Group
Sponsor:
Information provided by:
Japan Liver Oncology Group
ClinicalTrials.gov Identifier:
NCT00822991
First received: January 14, 2009
Last updated: December 29, 2010
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
Liver Cirrhosis
Hepatitis B
Hepatitis C
 Device: CE-US (Sonazoid™)
Device: B-mode US

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sonazoid Enhanced Liver Cancer Trial for Early Detection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Japan Liver Oncology Group:

Primary Outcome Measures:
  • Size of HCC which is detected first [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to detection of HCC [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • The improvement of prognosis of patients who are diagnosed in this study [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 760
Study Start Date: January 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: B-mode Group

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822991

Contacts
Contact: Masatoshi Kudo, professor +81-72-366-0221 ext 3149 m-kudo@med.kindai.ac.jp
Contact: Kazuomi Ueshima, lecturer +81-72-366-0221 ext 3525 kaz-ues@med.kindai.ac.jp

Locations
Japan
Kinki University School of Medicine, Department of Gastroenterology and Hepatology Recruiting
Osaka-Sayama, Osaka, Japan, 589-8511
Contact: Masatoshi Kudo, professor     +81-72-366-0221 ext 3149     m-kudo@med.kindai.ac.jp    
Contact: Kazuomi Ueshima, lecturer     +81-72-366-0221 ext 3525     kaz-ues@med.kindai.ac.jp    
Sponsors and Collaborators
Japan Liver Oncology Group
Investigators
Principal Investigator: Masatoshi Kudo, professor Japan Liver Oncology Group
  More Information

No publications provided by Japan Liver Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Japan Liver Oncology Group, Kinki University School of Medicine, Gastroenterology and Hepatology
ClinicalTrials.gov Identifier: NCT00822991     History of Changes
Other Study ID Numbers: JLOG08001, UMIN000001612
Study First Received: January 14, 2009
Last Updated: December 29, 2010
Health Authority: Japan: Institutional Review Board

Keywords provided by Japan Liver Oncology Group:
Sonazoid
Early detection
Hepatocellular carcinoma
Liver cirrhosis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Hepatitis, Viral, Human
Carcinoma
Liver Cirrhosis
Fibrosis
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Adenocarcinoma

ClinicalTrials.gov processed this record on May 22, 2013