UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014400
Receipt number 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 14:03:52

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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 or person

Institute

Faculty of Medicine, University of Tsukuba, Medical Science

Institute

Department

Personal name



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

Value
https://center6.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