Sonazoid Enhanced LivEr Cancer Trial for Early Detection

UMIN ID: UMIN000001612

Registered date:01/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hepatitis B virus or Hepatitis C virus related liver cirrhosis
• Date of first enrollment: 2009/01/01
• Target sample size: 760
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

<Group of CE-US> screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
<Group of B-mode US> screening by conventional B-mode US every 3-5 months

Outcome(s)

• Primary Outcome: Size of HCC which is detected first
• Secondary Outcome: 1) Time to detection of HCC 2) Number of HCC which is detected first 3) Stage of HCC which is detected first 4) The ability of definitive diagnosis of HCC 5) Sensitivity, Specificity and accuracy of the diagnosis of HCC 6) The improvement of prognosis of patients who are diagnosed in this study 7) The accumulated rate of detection of HCC

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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) Paients receiving interferon 6) Age under 20 7) Judged by investigator not to be appropriate for inclusion in this study

Related Information

• Primary Sponsor: Japan Liver Oncology Group (JLOG)
• Source(s) of Monetary Support: Japan Liver Oncology Group (JLOG)