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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041198
Receipt No. R000047039
Scientific Title Evaluation of hepatic viscoelasticity by Multifrequency Magnetic Resonance Elastography (MMRE)
Date of disclosure of the study information 2020/08/01
Last modified on 2020/08/07

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Basic information
Public title Evaluation of hepatic viscoelasticity by Multifrequency Magnetic Resonance Elastography (MMRE)
Acronym Multifrequency Magnetic Resonance Elastography (MMRE)
Scientific Title Evaluation of hepatic viscoelasticity by Multifrequency Magnetic Resonance Elastography (MMRE)
Scientific Title:Acronym Multifrequency Magnetic Resonance Elastography (MMRE)
Region
Japan

Condition
Condition Chronic liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison between hepatic viscoelasticity measured by MMRE and liver histology
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison between hepatic viscoelasticity measured by MMRE and liver biopsy or liver resection tissue
Key secondary outcomes Comparison between Share wave elastograpy (SWE) and multi-frequency excitation MRE

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.Patients with chronic liver disease such as (a) related to hepatitis virus, (b) nonalcoholic fatty liver disease (NAFLD), (c) nonalcoholic steatohepatitis (NASH), etc.
2.Age: Twenty (20) to ninety (90) years old (at the time of informed consent acquisition)
3.Patients who can follow instructions such as breath-holding.
Key exclusion criteria 1.Patients considered unsuitable for MRI due to claustrophobia, magnetic substances, etc.
2.Patients considered to have difficulty in examination because of mental illness or mental symptoms
3.Patients with serious complications in other organs
4.Pregnant or nursing women
5.Patients who did not accept informed consent of the examination
6.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 Hidenori
Middle name
Last name Toyoda
Organization Ogaki Municipal Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 5038502
Address 4-86 Minaminokawa-cho, Ogaki-shi, Gifu-ken
TEL +81-584-81-3341
Email hmtoyoda@spice.ocn.ne.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Kumada
Organization Gifu Kyoritsu University
Division name Department of Nursing, Faculty of Nursing
Zip code 5038550
Address 5-50, Kitagata-cho, Ogaki-shi, Gifu-ken
TEL +81-584-77-3512
Homepage URL
Email takashi.kumada@gmail.com

Sponsor
Institute Ogaki Municipal Hospital
Institute
Department

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

Other related organizations
Co-sponsor Shinshu University School of Medicine
Yokohama City University
Musashino Red-Cross Hospital
Gifu Kyoritsu University
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Ogaki Municipal Hospital
Address 4-86 Minaminokawa, Ogaki, Gifu, Japan, 503-8502
Tel +81-584-81-3341
Email clinical-trial@omh.ogaki.gifu.jp

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
2020 Year 08 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 200
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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
2018 Year 12 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 09 Month 30 Day

Other
Other related information Liver elasticity and viscosity measured by MMRE were compared with histological findings obtained from liver biopsy or hepatectomy. Then, we aimed to clarify which items of the tissue findings the elasticity and viscosity are related to.

Management information
Registered date
2020 Year 07 Month 22 Day
Last modified on
2020 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047039

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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