Sonazoid Enhanced Liver Cancer Trial for Early Detection | NCT00822991

Studies
Sonazoid Enhanced Liver Cancer Trial for Early Detection

NCT00822991

Sponsor

Kindai University

Status

Unknown status

Last Update Posted

Dec 30, 2010Estimated

Enrollment

760Estimated

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma
Liver Cirrhosis
Hepatitis B
Hepatitis C

Interventions

CE-US (Sonazoid™)
B-mode US

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UMIN000001612

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jan 14, 2009

First Submission Date that Met QC Criteria

Jan 14, 2009

First Posted Date

Jan 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2010

Last Update Posted Date

Dec 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

760Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group of CE-US	Active Comparator	screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months	Device: CE-US (Sonazoid™)
Group of B-mode US	Active Comparator	screening by conventional B-mode US every 3-5 months	Device: B-mode US

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CE-US (Sonazoid™)	Device	screening by CE-US using Sonazoid(TM) in the postvascular phase every 3-5 months	Group of CE-US

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Size of HCC which is detected first		10 years

Secondary Outcomes

Measure	Description	Time Frame
Time to detection of HCC		10 years
The improvement of prognosis of patients who are diagnosed in this study		10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Judged by investigator not to be appropriate for inclusion in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Masatoshi Kudo, professor	Contact	+81-72-366-0221	3149	m-kudo@med.kindai.ac.jp
Kazuomi Ueshima, lecturer	Contact	+81-72-366-0221	3525	kaz-ues@med.kindai.ac.jp

Overall Officials

Name	Affiliation	Role
Masatoshi Kudo, professor	Kindai University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kinki University School of Medicine, Department of Gastroenterology and Hepatology	Recruiting	Ōsaka-sayama	Osaka	589-8511	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21301463	Derived	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.

ID	Term
D006528	Carcinoma, Hepatocellular
D008103	Liver Cirrhosis
D006509	Hepatitis B
D006526	Hepatitis C

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type