Sonazoid Enhanced Liver Cancer Trial for Early Detection

NCT ID: NCT00822991

Last Updated: 2010-12-30

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

760 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Liver Cirrhosis Hepatitis B Hepatitis C

Keywords

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Sonazoid Early detection Hepatocellular carcinoma Liver cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

CE-US (Sonazoid™)

Intervention Type DEVICE

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

Group Type ACTIVE_COMPARATOR

B-mode US

Intervention Type DEVICE

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

Intervention Type DEVICE

B-mode US

screening by conventional B-mode US every 3-5 months

Intervention Type DEVICE

Other Intervention Names

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Sonazoid Group B-mode Group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kindai University

OTHER

Sponsor Role lead

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

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Masatoshi Kudo, professor

Role: CONTACT

Phone: +81-72-366-0221

Email: [email protected]

Kazuomi Ueshima, lecturer

Role: CONTACT

Phone: +81-72-366-0221

Email: [email protected]

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.

Reference Type DERIVED
PMID: 21301463 (View on PubMed)

Other Identifiers

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UMIN000001612

Identifier Type: -

Identifier Source: secondary_id

JLOG08001

Identifier Type: -

Identifier Source: org_study_id