UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of Cartesian and non-Cartesian acquisition technique in three-dimensional cine phase contrast magnetic resonance imaging (3D cine PC MRI) for analysis of blood flow dynamics within human vessels.
Title of the study (Brief title)	Comparative study of 4D-flow and PC-VIPR.
Region	Japan

Condition
Condition	Aortic artery
Classification by specialty	Vascular surgery Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	There are mainly two different techniques used for acquisition of 3D cine PC MR data; Cartesian acquisition technique and non-Cartesian radial acquisition technique. Recently GE healthcare company has brought out a 3D cine PC MRI sequence that uses Cartesian acquisition technique. This sequence was based on a Cartesian 3D cine PC MRI developed by Stanford University, which is called 4D Flow in a narrow sense. Wisconsin University has also developed a 3D cine PC MRI with non-Cartesian radial data acquisition called PC-VIPR. The purpose of this joint study is to compare and investigate the consistency of the 3D cine PC MRI data using the Cartesian methods and the non-Cartesian method.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Flow velocity within blood vessels, and various flow dynamics parameters (wall shear stress, oscillatory shear index, gradient oscillatory number) derived from the datasets of two 4DFlow sequences and PC-VIPR.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	The three-dimensional cine phase contrast magnetic resonance imaging using Cartesian method.
Interventions/Control_2	The three-dimensional cine phase contrast magnetic resonance imaging using non-Cartesian method.
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	Healthy volunteer who is twenty years old or older, with written informed concent.
Key exclusion criteria	1.People who can not take MRI(for example,people who have claustrophobia,devices which is unsupported for MRI,etc) 2. People who have past history of cardiovascular or arterial disease. 3. People who have past history of operation, stentgraft, metallic coil in the imaging area. 4.Woman who is pregnant or may be pregnant
Target sample size	5

Research contact person
Name of lead principal investigator	Takasuke Ushio
Organization	Hamamatsu Univercity school of medicine
Division name	Department of diagnostic radiology and nuclear medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL	053-435-2242
Email	tushio@hama-med.ac.jp

Public contact
Name of contact person	Takasuke Ushio
Organization	Hamamatsu Univercity school of medicine
Division name	Department of diagnostic radiology and nuclear medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan 431-3192
TEL	053-435-2242
Homepage URL
Email	tushio@hama-med.ac.jp

Sponsor
Institute	Hamamatsu Univercity school of medicine
Institute
Department

Funding Source
Organization	GE Healthcare Japan
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 05 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 14 Day
Anticipated trial start date	2016 Year 09 Month 23 Day
Last follow-up date
Date of closure to data entry	2017 Year 07 Month 01 Day
Date trial data considered complete	2017 Year 07 Month 01 Day
Date analysis concluded	2017 Year 07 Month 01 Day

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

Management information
Registered date	2017 Year 05 Month 23 Day
Last modified on	2017 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031463