UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility of Virtual UnEnhanced (VUE) algorithm for Dual-energy CT in liver fat estimation
Title of the study (Brief title)	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	Kazunari Ishii
Organization	Kindai University Faculty of Medicine
Division name	Department of Radiology
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	Tomoko HYODO
Organization	Kindai University Faculty of Medicine
Division name	Department of Radiology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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