Sonazoid Enhanced Liver Cancer Trial for Early Detection
NCT ID: NCT00822991
Last Updated: 2010-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
760 participants
INTERVENTIONAL
2009-01-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Group of CE-US
screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months
CE-US (Sonazoid™)
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
B-mode US
screening by conventional B-mode US every 3-5 months
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Kindai University
OTHER
Responsible Party
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Kinki University School of Medicine, Gastroenterology and Hepatology
Principal Investigators
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Masatoshi Kudo, professor
Role: PRINCIPAL_INVESTIGATOR
Kindai University
Locations
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Kinki University School of Medicine, Department of Gastroenterology and Hepatology
Ōsaka-sayama, Osaka, Japan
Countries
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Central Contacts
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Facility Contacts
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Masatoshi Kudo, professor
Role: primary
Kazuomi Ueshima, lecturer
Role: backup
References
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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.
Other Identifiers
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UMIN000001612
Identifier Type: -
Identifier Source: secondary_id
JLOG08001
Identifier Type: -
Identifier Source: org_study_id