UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Non-Contrast-Enhanced MR Angiography for Selective Visualization of the Hepatic Vein in Living Liver Donors Using MPRAGE on 3T MRI.
Title of the study (Brief title)	Visualization of Hepatic Vein in Living Liver Donors with Optimized Liver-Parenchyma-Nulled MPRAGE at 3T.
Region	Japan

Condition
Condition	living liver donors
Classification by specialty	Hepato-biliary-pancreatic surgery Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the usefulness of non-contrast-enhanced MR angiography using MPRAGE technique for selective visualization of hepatic vein in living liver donor candidates
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic performance
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Living Liver Donor Candidates
Key exclusion criteria	1 With a pacemaker 2 With any magnetic metal objects in a body 3 Unable to communicate with others 4 With claustrophobia 5 Pregnant woman
Target sample size	40

Research contact person
Name of lead principal investigator	Kaori Togashi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Diagnostic Imaging and Nuclear Medicine
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL	075-751-3760
Email	nmdioffice@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Rikiya Yamashita
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Diagnostic Imaging and Nuclear Medicine
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL	075-751-3760
Homepage URL
Email	rickdom@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

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)

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	2014 Year 05 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 08 Day
Anticipated trial start date	2014 Year 08 Month 01 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	Observational study acquiring the new data

Management information
Registered date	2014 Year 05 Month 08 Day
Last modified on	2016 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015872