UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041198 |
|---|---|
| Receipt number | 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 | 2023/03/05 13:50:51 |
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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
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
takashi.kumada@gmail.com
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
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
Saga University,Faculty 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
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
| 2023 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047039
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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