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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014400
Receipt No. R000016673
Scientific Title Usefulness of contrast-enhanced ultrasonography with Sonazoid for diagnosis and liver function assessment for Non-alcoholic steatohepatitis (NASH).
Date of disclosure of the study information 2014/07/01
Last modified on 2014/06/27

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Basic information
Public title Usefulness of contrast-enhanced ultrasonography with Sonazoid for diagnosis and liver function assessment for Non-alcoholic steatohepatitis (NASH).
Acronym Diagnosis and liver function assessment for Non-alcoholic steatohepatitis (NASH).
Scientific Title Usefulness of contrast-enhanced ultrasonography with Sonazoid for diagnosis and liver function assessment for Non-alcoholic steatohepatitis (NASH).
Scientific Title:Acronym Diagnosis and liver function assessment for Non-alcoholic steatohepatitis (NASH).
Region
Japan

Condition
Condition non-alcoholic fatty liver disease; NAFLD
Classification by specialty
Hepato-biliary-pancreatic medicine Laboratory medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Using an ultrasound contrast agent (Sonazoid), the phagocytosis function of the liver imaging effect and a kupffer cell is evaluated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NASH is efficiently picked up from the patient population of a non-alcoholic fatty liver.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Estimate the value phagocytosis function of Kupffer cells.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Outpatient with NAFLD not accordant to inappropriate condition.
The person judged appropriate by principal doctor and investigator.
Normal subjects not accordant to inappropriate condition.

Criterion of selection is the person with BMI more than 18.5 and less than 25.0 (criterion of Japan Society of the Study of Obesity) and without liver disease.
Key exclusion criteria Under 18 years old.
History of allergy to ingredients of this agent.
Allergy to eggs or dairy products.
Arteriovenous shunt at heart or lung.
Heart disease.
Lung disease.
Disagree with participation in this investgation.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Shoda
Organization Faculty of Medicine, University of Tsukuba
Division name Medical Science
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-5795
Email shodaj@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Shida
Organization Faculty of Medicine, University of Tsukuba
Division name Medical Science
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-3291
Homepage URL
Email shida.mim03@gmail.com

Sponsor
Institute Faculty of Medicine, University of Tsukuba, Medical Science
Institute
Department

Funding Source
Organization Ministry of Education, Science and Culture
Organization
Division
Category of Funding Organization
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
2014 Year 07 Month 01 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 Open public recruiting
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 27 Day
Last modified on
2014 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016673

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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