UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041320 |
|---|---|
| Receipt number | 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 09:53:49 |
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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
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
crc-kenkyu@nanpuh.or.jp
Sponsor or person
Institute
Public interest incorporated association Kagoshima Kyosaikai Nanpu Hospital
Liver internal medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046937
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