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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024151
Receipt No. R000027810
Scientific Title Feasibility of Virtual UnEnhanced (VUE) algorithm for Dual-energy CT in liver fat estimation
Date of disclosure of the study information 2016/09/24
Last modified on 2018/09/25

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Basic information
Public title Feasibility of Virtual UnEnhanced (VUE) algorithm for Dual-energy CT in liver fat estimation
Acronym Feasibility of Virtual UnEnhanced (VUE) algorithm for Dual-energy CT in liver fat estimation
Scientific Title Feasibility of Virtual UnEnhanced (VUE) algorithm for Dual-energy CT in liver fat estimation
Scientific Title:Acronym Feasibility of Virtual UnEnhanced (VUE) algorithm for Dual-energy CT in liver fat estimation
Region
Japan Asia(except Japan)

Condition
Condition Fatty liver
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess feasibility of virtual non-contract CT imaging in the evaluation of fat quantification of the liver in comparison with real non-contrast images.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The visual detectability of fatty liver by using needle biopsy as reference standard.
Key secondary outcomes (1) ROI assessment of the liver parenchyma and the spleen
(2) Radiation dose

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who will undergo dynamic contrast-enhanced CT of the liver due to suspected or known fatty liver disease within 4 weeks prior to liver biopsy.
Key exclusion criteria Patients with severe comorbidities which can pose a problem for performing CT exam
Images with non-diagnostic image quality caused by presence of artifacts or inadequate scan timing
Multiple liver masses
Abnormal hemodynamics in the liver due to portal venous thrombosis, etc.
Patients ineligible for dynamic contrast-enhanced CT due to other reason
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunari Ishii
Organization Kindai University Faculty of Medicine
Division name Department of Radiology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, JAPAN
TEL 072-366-0221
Email ishii@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko HYODO
Organization Kindai University Faculty of Medicine
Division name Department of Radiology
Zip code
Address 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511, JAPAN
TEL 072-366-0221
Homepage URL
Email thyodo@med.kindai.ac.jp

Sponsor
Institute The Department of Radiology,
Kindai University Faculty of Medicine, 377-2 Ohno-higashi, Osaka-Sayama, Osaka 589-8511,
Japan
Institute
Department

Funding Source
Organization Department of Radiology,
Kindai University Faculty of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor 1) Department of Radiology, Osaka University Graduate School of Medicine
2) Department of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Korea
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 近畿大学医学部附属病院(大阪府)、大阪大学附属病院(大阪府)、Samsung Medical Center, Sungkyunkwan University School of Medicine (韓国)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 24 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 Terminated
Date of protocol fixation
2016 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cross-sectional study
Time from IRB Approval to Aug 31 2017
Patients with clinically suspected fatty liver (due to liver-kidney contrast on ultrasound and/or elevated liver enzymes with unknown etiology) and planned liver biopsy
Qualitative and quantitative assessment of virtual unenhanced CT images

Management information
Registered date
2016 Year 09 Month 24 Day
Last modified on
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027810

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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