UMIN-CTR Clinical Trial

Basic information
Public title	Development and clinical application of superselective 4D-MRA for intracranial blood vessels
Acronym	Development and clinical application of superselective 4D-MRA for intracranial blood vessels
Scientific Title	Development and clinical application of superselective 4D-MRA for intracranial blood vessels
Scientific Title:Acronym	Development and clinical application of superselective 4D-MRA for intracranial blood vessels
Region	Japan

Condition
Condition	Cerebrovascular disease
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the development and clinical application of superselective 4D-MRA in intracranial blood vessels.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Establishment of optimal imaging parameters and imaging method
Key secondary outcomes	Shortened acquisition time and improved temporal resolution

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Intervention test on MRI examination
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy adult
Key exclusion criteria	Subject with contraindications to MRI Subject with metallic implants Claustrophobic Pregnant
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Osamu Middle name Last name Togao
Organization	Kyushu University Hospital
Division name	Radiology
Zip code	8128582
Address	3-1-1, Maidashi, Higashi-ku,Fukuoka-shi,Fukuoka
TEL	092-642-5695
Email	togao@radiol.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Osamu Middle name Last name Togao
Organization	Kyushu University Hospital
Division name	Radiology
Zip code	8128582
Address	3-1-1, Maidashi, Higashi-ku,Fukuoka-shi,Fukuoka
TEL	092-642-5695
Homepage URL
Email	togao@radiol.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for Clinical and Translational Research of Kyushu University Hospital
Address	3-1-1, Maidashi, Higashi-ku,Fukuoka-shi,Fukuoka
Tel	092-642-5774
Email	bynintei@jimu.kyushu-u.ac.jp

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	2020 Year 05 Month 01 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	Open public recruiting
Date of protocol fixation	2020 Year 04 Month 06 Day
Date of IRB	2020 Year 04 Month 06 Day
Anticipated trial start date	2020 Year 04 Month 06 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 15 Day
Last modified on	2020 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045781

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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