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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028921
Receipt No. R000033091
Scientific Title Virtual Unenhanced Algorithms for Fast-Kilovolt Switching Dual-Energy CT: Retrospective Comparison Between Dedicated and Non-dedicated Softwares for Assessment of Liver Fat Content
Date of disclosure of the study information 2017/08/31
Last modified on 2018/03/26

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Basic information
Public title Virtual Unenhanced Algorithms for Fast-Kilovolt Switching Dual-Energy CT: Retrospective Comparison Between Dedicated and Non-dedicated Softwares for Assessment of Liver Fat Content
Acronym Virtual Unenhanced Algorithms for Fast-Kilovolt Switching Dual-Energy CT: Retrospective Comparison Between Dedicated and Non-dedicated Softwares for Assessment of Liver Fat Content
Scientific Title Virtual Unenhanced Algorithms for Fast-Kilovolt Switching Dual-Energy CT: Retrospective Comparison Between Dedicated and Non-dedicated Softwares for Assessment of Liver Fat Content
Scientific Title:Acronym Virtual Unenhanced Algorithms for Fast-Kilovolt Switching Dual-Energy CT: Retrospective Comparison Between Dedicated and Non-dedicated Softwares for Assessment of Liver Fat Content
Region
Japan

Condition
Condition Fatty liver disease
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the accuracy of the dedicated and non-dedicated virtual unenhanced (VUE) algorithms for liver fat content estimation by using fast kV-switching dual-energy CT (DECT).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare measurements of the liver tissue on images reconstructed with the dedicated and non-dedicated virtual unenhanced (VUE) algorithms.
Key secondary outcomes (1) Intra- and inter- observer reliability
(2)Estimation of radiation dose

Base
Study type Others,meta-analysis etc

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 Dual-energy data of hepatic dynamic CT acquired from July 2011 to July 2012
Key exclusion criteria (1) Multiple lesions in the liver
(2) Inappropriate quality of images
Target sample size 45

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

Sponsor
Institute The Department of Radiology,
Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization None
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
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)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2017 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 11 Month 15 Day

Other
Other related information Retrospective study

Management information
Registered date
2017 Year 08 Month 30 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033091

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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