UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057383 |
|---|---|
| Receipt number | R000064962 |
| Scientific Title | A study of quantitative assessment of liver with magnetic resonance imaging in normal volunteers |
| Date of disclosure of the study information | 2025/04/07 |
| Last modified on | 2026/04/01 16:23:35 |
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Basic information
Public title
A study of quantitative MRI assessment of normal liver
Acronym
quantitative MRI assessment of normal liver
Scientific Title
A study of quantitative assessment of liver with magnetic resonance imaging
in normal volunteers
Scientific Title:Acronym
quantitative MRI assessment of normal liver (QMAoNL) Study
Region
| Japan |
Condition
Condition
Chronic liver disease, Fatty liver, Cirrhosis of the liver,Hemochromatosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantitative MRI imaging quantifies and visualizes the physical characteristics of tissues and lesions. Quantitative liver imaging techniques, including MR elastography (MRE), proton density fat fraction (PDFF), T2* mapping, and R2* mapping,MR spectroscopy(MRS), are considered useful for diagnosis, treatment efficacy assessment, and follow-up. While invasive liver biopsy remains the gold standard for diagnosing chronic liver disease, non-invasive imaging tests are becoming increasingly popular. However, it cannot be overlooked that the quantitative values obtained from liver MRI examinations in clinical practice may vary depending on the imaging device, technique, and conditions, potentially affecting the results. Therefore, it is crucial to evaluate inter-model differences in quantitative images acquired using multiple MRI systems at our hospital.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shear Modulus, PDFF, T2* value, R2* value
Key secondary outcomes
Influence of imaging models, imaging methods, and imaging conditions on images and quantitative values in MRE, PDFF, T2* mapping, and R2* mapping,MRS.
The relationship between examination values and elastic modulus, PDFF, T2*, and R2* values.
The relationship between fat content and tissue stiffness obtained from ultrasonography and MRI scans.
Normal values categorized by liver segment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Normal liver function confirmed in the most recent health examination (either the previous or current year).
No history of liver disease.
No risks for MRI examination (no claustrophobia and no implanted magnetic devices)
Provide consent to participate in this study.
Maintain a normal BMI (between 18.5 and 25.0).
Key exclusion criteria
History of liver disease.
Risks for MRI examination; i.e. claustrophobia, magnetic implants (pacemakers, artificial joints, implanted metals), colored contacts, eye shadow, tattoos, etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ito |
Organization
Fukushima Medical University Hospital
Division name
Department of Radiology and Nuclear Medicine
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
024-547-1485ext.6283
rad@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Emiya |
| Middle name | |
| Last name | Koike |
Organization
Fukushima Medical University Hospital
Division name
Department of Radiology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL
024-547-1485ext.3456
Homepage URL
koike36@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Fukushima Medical University Hospital
Address
1 Hikarigaoka, Fukushima City, Fukushima Prefecture
Tel
024-547-1485
fmurec@fmu.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
| 2025 | Year | 04 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted on healthy adult volunteers with normal liver function. The recruitment condition is that the AST, ALT, and rGTP levels are all within the normal range at the most recent physical examination (previous year or the current year). Since the reference value of the normal range differs depending on the facility in charge of the physical examination, the reference value determined by the facility in question will be used. MRI will be performed on healthy adult volunteers who agree to undergo MRI using the four MRI machines available at the hospital. The recruitment period will be from March 2025 to December 2026. The MRI will be performed with sequences used in liver screening, including quantitative MRE, PDFF, T2 star mapping, and R2 star mapping,MRS. The examination time is approximately 90 minutes, including entry and exit. All safety precautions during the examination are the same as those used for MRI examinations in the hospital to ensure the safety of the subject. From the MRI images, diseases that may affect quantitative values, such as fatty liver, cirrhosis, and tumors, are denied. Then, a region of interest (ROI) is established for the quantitative images and the quantitative values are measured.
By April 1, 2026, a total of six cases had been completed.
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064962
