UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000041902
Receipt number	R000047828
Scientific Title	Prospective study for evaluating hepatic steatosis using Ultrasound-guided attenuation parameter (UGAP) and Controlled Attenuation Parameter (CAP) by comparison with MRI-determined proton density fat fraction (PDFF)
Date of disclosure of the study information	2020/09/27
Last modified on	2023/09/30 09:13:27

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Basic information

Public title

Prospective study for evaluating hepatic steatosis using Ultrasound-guided attenuation parameter (UGAP) and Controlled Attenuation Parameter (CAP) by comparison with MRI-determined proton density fat fraction (PDFF)

Acronym

Ultrasound-guided attenuation parameter (UGAP) vs Controlled Attenuation Parameter (CAP) study

Scientific Title

Scientific Title:Acronym

Ultrasound-guided attenuation parameter (UGAP) vs Controlled Attenuation Parameter (CAP) study

Region

Japan

Condition

chronic liver disease

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Evaluation of hepatic steatosis by UGAP and CAP

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Assessment

Primary outcomes

We assess the accuracy of UGAP and CAP in assessing hepatic steatosis compared to PDFF

Key secondary outcomes

We verify whether UGAP and CAP can diagnose fatty liver (liver fat content 5% or more)

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1.NAFLD patients who underwent UGAP, CAP and PDFF within 3 months
2. As control subjects without steatosis, patients with chronic liver disease including viral hepatitis, NAFLD, autoimmune hepatitis, primary biliary cholangitis, and so on.
3.Patients who can follow instructions such as breath-holding.

Key exclusion criteria

1.Patients without claustrophobia
2.Patients without magnetic substance or tattoo
3.Patients without pacemakers
4.Patients who are pregnant
5.Patients judged as inappropriate for the study by the study responsibility (share) physician.

Target sample size

200

Research contact person

Name of lead principal investigator

1st name Kento

Middle name

Last name Imajo

Organization

Yokohama City University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Japan

TEL

+81457872640

Email

kento_impact@yahoo.co.jp

Public contact

Name of contact person

1st name Kento

Middle name

Last name Imajo

Organization

Yokohama City University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

2360004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Japan

TEL

+81457872640

Homepage URL

Email

kento318@yokohama-cu.ac.jp

Sponsor or person

Institute

Yokohama City University School of Medicine
Department of Gastroenterology and Hepatology

Institute

Department

Personal name

Funding Source

Organization

GE Precision Healthcare

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Yokohama City University School of Medicine

Address

3-9 Fukuura, Kanazawa-ku, Yokohama, Japan

Tel

+81457872800

Email

kento318@yokohama-cu.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 27 Day

Related information

URL releasing protocol

none

Publication of results

Unpublished

Result

URL related to results and publications

UGAP is useful compared to CAP

Number of participants that the trial has enrolled

200

Results

UGAP is useful compared to CAP

Results date posted

2023 Year 09 Month 30 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

200

Participant flow

200

Adverse events

none

Outcome measures

UGAP>CAP

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2019 Year 07 Month 22 Day

Date of IRB

2019 Year 12 Month 13 Day

Anticipated trial start date

2020 Year 02 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Acquisition of the optimal cut-off values for the diagnosis of hepatic steatosis. Academical manuscripts and clinical presentations on the results.

Management information

Registered date

2020 Year 09 Month 27 Day

Last modified on

2023 Year 09 Month 30 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047828

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name