UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040636 |
|---|---|
| Receipt number | R000046290 |
| Scientific Title | Evaluation of quantitative analysis of liver fibrosis by IVIM-DWI and Fibroscan in chronic liver disease. |
| Date of disclosure of the study information | 2020/06/10 |
| Last modified on | 2023/12/06 09:56:43 |
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Basic information
Public title
Evaluation of quantitative analysis of liver fibrosis by IVIM-DWI and Fibroscan in chronic liver disease.
Acronym
Evaluation of quantitative analysis of liver fibrosis by IVIM-DWI and Fibroscan in chronic liver disease.
Scientific Title
Evaluation of quantitative analysis of liver fibrosis by IVIM-DWI and Fibroscan in chronic liver disease.
Scientific Title:Acronym
Evaluation of quantitative analysis of liver fibrosis by IVIM-DWI and Fibroscan in chronic liver disease.
Region
| Japan |
Condition
Condition
chronic liverdisease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of IVIM-DWI as a quantitative evaluation method of liver fibrosis in comparison with Fibroscan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To confirm the advantages of IVIM-DWI quantitative evaluation compared with Fibroscan
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Acquisition of MRI images
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Chronic liver impairment is suspected, and MRI of liver, blood test, and Fibroscan were performed. Pathological examination is not mandatory.
2.Hematological tests (hemoglobin, white blood cell count, white blood cell fraction, platelet count), and blood biochemical tests (ALP, total bilirubin, albumin, AST, ALT, total protein, LDH, HbA1C, ChE, total cholesterol, type) 4 collagen and M2GPI are included).
3.Patients who obtained written informed consent from the patient during the echo examination and MRI examination (includ IVIM-DWI examination)
Key exclusion criteria
1.Those who noticeably deteriorated image quality due to physical movement during the process.
2.Those who discontinue the test due to claustrophobia.
3.Those who refuse to participate due to disclosure of research information.
4.Those who the research director judges to be inappropriate as a research target.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Murakami |
Organization
Juntendo University Hospital
Division name
Radiology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
k-murakami@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Murakami |
Organization
Juntendo University Hospital
Division name
Radiology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
k-murakami@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee in Juntendo university hospital
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
kenkyu5858@juntendo.ac.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 | 06 | Month | 10 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
26
Results
A weak correlation was observed between fibroscan and liver fibrosis markers and F IVIM, D*, suggesting that gender may be a confounding factor. IVIM-DWI alone should not be used as an index of liver cirrhosis, but should be comprehensively evaluated with other fibrosis markers and fibroscan.
Results date posted
| 2023 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
chronic hepatitis 26cases
Participant flow
MRI (IVIM-DWI) was performed and FIVIM, D*, and D values were measured. Furthermore, Fibroscan was performed and compared with the value of VCTE. We also measured liver fibrosis markers by blood test.
Adverse events
none
Outcome measures
Multivariate analysis of VCTE, an index of liver stiffness of Fibroscan, Type4 collagen, M2 GPI, P3P, FIB-4 index, an index of liver fibrosis, and F IVIM, D*, D values, an index of IVIM-DWI The relevance was analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 03 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046290
