UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055021 |
|---|---|
| Receipt number | R000062734 |
| Scientific Title | Imaging biomarkers exploring the pathophysiology of diffuse liver disease |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2024/07/19 11:45:16 |
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Basic information
Public title
Imaging biomarkers exploring the pathophysiology of diffuse liver disease
Acronym
Imaging Biomarkers of Diffuse Liver Disease
Scientific Title
Imaging biomarkers exploring the pathophysiology of diffuse liver disease
Scientific Title:Acronym
Imaging Biomarkers of Diffuse Liver Disease
Region
| Japan |
Condition
Condition
Normal volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the relationship between viscoelasticity and water diffusion in the liver by correlating viscoelasticity measurements by MR elastography with US biomarkers (SWS/DS/ATI) and MR biomarkers (T1 value/ADC value). Furthermore, we will propose an optimal imaging biomarker to elucidate the pathogenesis of diffuse liver disease.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Are storage modulus (index of elasticity) and loss modulus (index of viscosity) properly obtained by MR elastography on the liver of normal volunteers?
Key secondary outcomes
Is there any correlation between the storage and loss moduli of the liver obtained by MR elastography and the SWS, DS, and ATI obtained by ultrasound?
Is there a correlation between the storage and loss elastic moduli of the liver obtained by MR elastography and the T1 value and apparent diffusion coefficient of MR?
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Persons with the ability to give written consent who wish to participate in this study
Those who have a BMI <25
Key exclusion criteria
Persons with a history of hepatobiliary surgery
Persons who are judged to have health problems by the investigator's physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Riwa |
| Middle name | |
| Last name | Kishimoto |
Organization
National Institutes for Quantum Science and Technology
Division name
QST Hospital
Zip code
2638555
Address
4-9-1, Anagawa, Inage-ku, Chiba
TEL
0432063360
kishimoto.riwa@qst.go.jp
Public contact
Name of contact person
| 1st name | Riwa |
| Middle name | |
| Last name | Kishimoto |
Organization
National Institutes for Quantum Science and Technology
Division name
QST hospital
Zip code
2638555
Address
4-9-1, Anagawa, Inage-ku, Chiba
TEL
0432063360
Homepage URL
kishimoto.riwa@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology
Address
4-9-1, Anagawa, Inage-ku, Chiba
Tel
0432063360
kishimoto.riwa@qst.go.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
量子科学技術研究開発機構
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
preinitiation
Management information
Registered date
| 2024 | Year | 07 | Month | 19 | Day |
Last modified on
| 2024 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062734
