UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056968 |
|---|---|
| Receipt number | R000065059 |
| Scientific Title | A Prospective Observational Study on the Establishment of a Novel Method for Assessing Steatotic Liver Disease Using Magnetic Resonance Imaging (MRI) |
| Date of disclosure of the study information | 2025/02/07 |
| Last modified on | 2025/02/07 13:48:18 |
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Basic information
Public title
A Prospective Observational Study on the Establishment of a Novel Method for Assessing Steatotic Liver Disease Using Magnetic Resonance Imaging (MRI)
Acronym
A Prospective Observational Study on the Establishment of a Novel Method for Assessing Steatotic Liver Disease Using Magnetic Resonance Imaging (MRI)
Scientific Title
A Prospective Observational Study on the Establishment of a Novel Method for Assessing Steatotic Liver Disease Using Magnetic Resonance Imaging (MRI)
Scientific Title:Acronym
A Prospective Observational Study on the Establishment of a Novel Method for Assessing Steatotic Liver Disease Using Magnetic Resonance Imaging (MRI)
Region
| Japan |
Condition
Condition
Steatotic Liver Disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a method for accurately quantifying the total hepatic fat content using MR images of steatotic liver disease with volume rendering software.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation between whole-liver MRI proton density fat fraction (PDFF) values and PDFF values based on region of interest (ROI) set for each liver segment.
Key secondary outcomes
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
Individuals who have been identified with steatotic liver or liver dysfunction through blood tests or imaging studies in general medical examinations or health check-ups within one year prior to study enrollment.
Key exclusion criteria
1. Individuals with a history or treatment history of liver diseases other than steatotic liver.
2. Individuals with an average daily pure ethanol intake of 30 g or more for men and 20 g or more for women.
3. Individuals who cannot undergo MRI due to the presence of metal implants in the body, claustrophobia, or other reasons.
4. Individuals who are unable to hold their breath for approximately 15 seconds.
5. Individuals with dementia or psychiatric disorders which make it difficult to understand the study.
6. Individuals deemed unsuitable by the principal investigator or the attending physician for other reasons.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Matsuda |
Organization
University of Tsukuba Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba
TEL
029-853-3053
matsuda.takaaki.dd@ms.hosp.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Matsuda |
Organization
University of Tsukuba Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
TEL
0298533053
Homepage URL
matsuda.takaaki.dd@ms.hosp.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research ethics committee of the University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3914
matsuda.takaaki.dd@ms.hosp.tsukuba.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 | 02 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study evaluating the total hepatic fat content using MR images of steatotic liver with volume rendering software.
Management information
Registered date
| 2025 | Year | 02 | Month | 07 | Day |
Last modified on
| 2025 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065059
