Sonazoid Enhanced Liver Cancer Trial for Early Detection
2 other identifiers
interventional
760
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hepatocellular-carcinoma
Started Jan 2009
Longer than P75 for not_applicable hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 14, 2009
CompletedFirst Posted
Study publicly available on registry
January 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedDecember 30, 2010
January 1, 2009
10.9 years
January 14, 2009
December 29, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Size of HCC which is detected first
10 years
Secondary Outcomes (2)
Time to detection of HCC
10 years
The improvement of prognosis of patients who are diagnosed in this study
10 years
Study Arms (2)
Group of CE-US
ACTIVE COMPARATORscreening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
Group of B-mode US
ACTIVE COMPARATORscreening by conventional B-mode US every 3-5 months
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kinki University School of Medicine, Department of Gastroenterology and Hepatology
Ōsaka-sayama, Osaka, 589-8511, Japan
Related Publications (1)
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.
PMID: 21301463DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Masatoshi Kudo, professor
Kindai University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 14, 2009
First Posted
January 15, 2009
Study Start
January 1, 2009
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
December 30, 2010
Record last verified: 2009-01