Sonazoid Enhanced Liver Cancer Trial for Early Detection

Hepatocellular Carcinoma Clinical Trial

Official title:

Sonazoid Enhanced Liver Cancer Trial for Early Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00822991
• Other study ID #: JLOG08001
• Secondary ID: UMIN000001612
• Status: Recruiting
• Phase: N/A
• First received: January 14, 2009
• Last updated: December 29, 2010
• Start date: January 2009
• Est. completion date: December 2019

Study information

• Verified date: January 2009
• Source: Japan Liver Oncology Group
• Contact: Masatoshi Kudo, professor
• Phone: +81-72-366-0221
• Email: m-kudo[@]med.kindai.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 760
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• Hepatocellular Carcinoma
• Liver Cirrhosis

Intervention

Device:
• CE-US (Sonazoid™)
screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
• B-mode US
screening by conventional B-mode US every 3-5 months

Locations

Country	Name	City	State
Japan	Kinki University School of Medicine, Department of Gastroenterology and Hepatology	Osaka-Sayama	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Japan Liver Oncology Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of HCC which is detected first		10 years	Yes
Secondary	Time to detection of HCC		10 years	Yes
Secondary	The improvement of prognosis of patients who are diagnosed in this study		10 years	Yes