Sonazoid Enhanced Liver Cancer Trial for Early Detection

This study is currently recruiting participants. (see Contacts and Locations)
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

January 14, 2009
December 29, 2010
January 2009
December 2019   (final data collection date for primary outcome measure)
Size of HCC which is detected first [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00822991 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Sonazoid Enhanced Liver Cancer Trial for Early Detection
Sonazoid Enhanced Liver Cancer Trial for Early Detection

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Hepatocellular Carcinoma
  • Liver Cirrhosis
  • Hepatitis B
  • Hepatitis C
  • Device: CE-US (Sonazoid™)
    screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
    Other Name: Sonazoid Group
  • Device: B-mode US
    screening by conventional B-mode US every 3-5 months
    Other Name: B-mode Group
  • Active Comparator: Group of CE-US
    screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
    Intervention: Device: CE-US (Sonazoid™)
  • Active Comparator: Group of B-mode US
    screening by conventional B-mode US every 3-5 months
    Intervention: Device: B-mode US
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
760
December 2019
December 2019   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
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
Japan
 
NCT00822991
JLOG08001, UMIN000001612
Yes
Japan Liver Oncology Group, Kinki University School of Medicine, Gastroenterology and Hepatology
Japan Liver Oncology Group
Not Provided
Principal Investigator: Masatoshi Kudo, professor Japan Liver Oncology Group
Japan Liver Oncology Group
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP