UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000041320
Receipt No. R000046937
Scientific Title Comparison of liver fibrosis by non-invasive MRI Elastography and Shear Wave Elastography in patients with chronic liver disease diagnosed by invasive biopsy and examination of non-alcoholic fatty liver disease by MRI Proton Density Fat Fraction method and frequency-dependent attenuation image
Date of disclosure of the study information 2020/08/13
Last modified on 2021/08/05 (Ver. 2)

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Basic information
Public title Comparison of liver fibrosis by non-invasive MRI Elastography and Shear Wave Elastography in patients with chronic liver disease diagnosed by invasive biopsy and examination of non-alcoholic fatty liver disease by MRI Proton Density Fat Fraction method and frequency-dependent attenuation image
Acronym Comparison of liver fibrosis by non-invasive MRI Elastography and Shear Wave Elastography in patients with chronic liver disease diagnosed by invasive biopsy and examination of non-alcoholic fatty liver disease by MRI Proton Density Fat Fraction method and frequency-dependent attenuation image
Scientific Title Comparison of liver fibrosis by non-invasive MRI Elastography and Shear Wave Elastography in patients with chronic liver disease diagnosed by invasive biopsy and examination of non-alcoholic fatty liver disease by MRI Proton Density Fat Fraction method and frequency-dependent attenuation image
Scientific Title:Acronym Comparison of liver fibrosis by non-invasive MRI Elastography and Shear Wave Elastography in patients with chronic liver disease diagnosed by invasive biopsy and examination of non-alcoholic fatty liver disease by MRI Proton Density Fat Fraction method and frequency-dependent attenuation image
Region
Japan

Condition
Condition






Patients with chronic liver disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Based on the histological liver fibrosis stage obtained by liver biopsy, which is an invasive test, liver tissue stages obtained by shear wave elastography and MRI elastography, which are non-invasive tests, were compared and examined by MRI PDFF method. And evaluating the diagnostic accuracy of NAFLD by frequency dependent attenuation image (ATI method)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes MRI elastography MRE (shear modulus)
Shear Wave Elastography SWE

Key secondary outcomes Blood test: white blood cell count, white blood cell fraction, hemoglobin, platelets, total protein, albumin, total bilirubin, direct bilirubin, AST, ALT, ALP, GGT, BUN, Cr, ferritin/liver fibrosis markers: Fib4 index, M2BPGi, 4 Type collagen 7s, MRI PDFF method: MRI PDFF value, frequency-dependent attenuation image (ATI method) Liver biopsy: Histological diagnosis of liver biopsy (HAI score)

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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with chronic liver diseases such as viral, drug-induced, autoimmune, non-alcoholic fatty liver disease (NAFLD).
2) Patients aged 20 to less than 85
Key exclusion criteria 1) Decompensated cirrhosis.
2) Patients with platelets less than 50,000/ml.
3) Patients with PT less than 40%.
4) Patients with bleeding tendency.
5) Alcoholic liver disease.
6) Patients who need consent from a legal representative.
7) Patients with claustrophobia
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yasuji
Middle name
Last name Komorizono
Organization Public interest incorporated association Kagoshima Kyosaikai Nanpu Hospital
Division name Hepatology
Zip code 892-8512
Address 14-3 Nagatacho, Kagoshima City, Kagoshima Prefecture,Japan
TEL 0992269111
Email y.komorizono@nanpuh.or.jp

Public contact
Name of contact person
1st name shuko
Middle name
Last name Minami
Organization Public interest incorporated association Kagoshima Kyosaikai Nanpu Hospital
Division name Clinical Research Support Office
Zip code 892-8512
Address 14-3 Nagatacho, Kagoshima City, Kagoshima Prefecture,
TEL 0992269111
Homepage URL
Email crc-kenkyu@nanpuh.or.jp

Sponsor
Institute Public interest incorporated association Kagoshima Kyosaikai Nanpu Hospital
Liver internal medicine
Institute
Department

Funding Source
Organization Public interest incorporated association Kagoshima Kyosaikai Nanpu Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Public interest incorporated association Kagoshima Kyosaikai Nanpu Hospital
Address 14-3 Nagatacho, Kagoshima City, Kagoshima Prefecture
Tel 0992269111
Email crc-kenkyu@nanpuh.or.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 13 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 Completed
Date of protocol fixation
2018 Year 04 Month 13 Day
Date of IRB
2018 Year 05 Month 29 Day
Anticipated trial start date
2018 Year 05 Month 29 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 Based on the histological liver fibrosis stage obtained by biopsy, we compared the liver tissue stage obtained by shear wave elastography and MRI elastography, which are non-invasive examination methods, and also examined the MRI PDFF method and frequency dependence. Evaluate the diagnostic accuracy of NAFLD by attenuation image (ATI method).










Management information
Registered date
2020 Year 08 Month 05 Day
Last modified on
2021 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046937