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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011330
Receipt No. R000013225
Scientific Title Non-invasive method for evaluating the development of interstitial structure and cancer malignancy using contrast-enhanced ultrasonography using Sonazoid
Date of disclosure of the study information 2013/07/31
Last modified on 2017/02/01

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Basic information
Public title Non-invasive method for evaluating the development of interstitial structure and cancer malignancy using contrast-enhanced ultrasonography using Sonazoid
Acronym Non-invasive method for evaluating the development of interstitial structure and cancer malignancy using contrast-enhanced ultrasonography using Sonazoid
Scientific Title Non-invasive method for evaluating the development of interstitial structure and cancer malignancy using contrast-enhanced ultrasonography using Sonazoid
Scientific Title:Acronym Non-invasive method for evaluating the development of interstitial structure and cancer malignancy using contrast-enhanced ultrasonography using Sonazoid
Region
Japan

Condition
Condition 1. malignant tumor in the liver
2. chronic liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop a non-invasive method of evaluating interstitial structure and malignancy in the liver
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Effectiveness of Sonazoid contrast ultrasound in the diagnosis and grade definitive diagnosis of malignancy
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria age; over 20 years
Gender: unquestioned
Patients with any of the following
1. And or, with malignant tumors, patients with malignant tumor is suspected
2. Chronic liver disease patients with malignant tumors
Key exclusion criteria Patients with a history of hypersensitivity to drug test
Patients who are allergic to egg products or egg
Patient nursing and pregnancy
Patients attending physician has determined is inappropriate participation in this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sawako Uchida
Organization Osaka City University Graduate School of Medicine
Division name Department of Hepatology
Zip code
Address 1-4-3 , Asahimachi, Abeno-ku, Osaka 545-8585, Japan.
TEL 06-6645-3905
Email sawako@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sawako Uchida
Organization Osaka City University Graduate School of Medicine
Division name Department of Hepatology
Zip code
Address 1-4-3 , Asahimachi, Abeno-ku, Osaka 545-8585, Japan.
TEL 06-6645-3905
Homepage URL
Email sawako@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Department of Hepatology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2009 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2013 Year 07 Month 31 Day
Last modified on
2017 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013225

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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