UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034319 |
|---|---|
| Receipt number | R000039043 |
| Scientific Title | Quantification of liver fat on ultrasound and magnetic resonance imaging |
| Date of disclosure of the study information | 2018/10/02 |
| Last modified on | 2022/10/01 09:45:19 |
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Basic information
Public title
Quantification of liver fat on ultrasound and magnetic resonance imaging
Acronym
Quantification of liver fat on ultrasound and magnetic resonance imaging
Scientific Title
Quantification of liver fat on ultrasound and magnetic resonance imaging
Scientific Title:Acronym
Quantification of liver fat on ultrasound and magnetic resonance imaging
Region
| Japan |
Condition
Condition
Normal adults
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify fat content in the liver using ultrasound (US) and magnetic resonance imaging(MRI) techniques, and evaluating the reliability of ultrasound as a liver fat quantification technique
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantification of liver fat
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults capable of decision-making
Key exclusion criteria
Persons with a history of renal disease
Persons with claustrophobia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ayako Taketomi-Takahashi |
Organization
Gunma University Hospital
Division name
Department of Nuclear Medicine
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma, JAPAN
TEL
027-220-8612
ayakorad@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayako Taketomi-Takahashi |
Organization
Gunma University Hospital
Division name
Department of Nuclear Medicine
Zip code
Address
3-39-22 Showa-machi, Maebashi, Gunma, JAPAN
TEL
027-220-8612
Homepage URL
ayakorad@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
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
Address
Tel
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
| 2018 | Year | 10 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2018 | Year | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039043
