UMIN-CTR Clinical Trial

Basic information
Public title	Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease
Acronym	Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease
Scientific Title	Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease
Scientific Title:Acronym	Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease
Region	Japan

Condition
Condition	occulusive cerebrobascular disease(moyamoya disease, ICA stenosis)
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the utility of the SMS DSC MRI for the diagnosis of occulusive cerebrobascular diseases including moyamoya disease or the other erebrobascular diseases such as ICA stgenosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The perfusion measurements as well as the image quality of CBF, CBV, MTT, TTP, Tmax maps, created with temporal resolution of 0.5s (high temporal resoltuion), and conventional temporal resolution of 1.0, 1.5, and 2.0s (low temopral resolution).
Key secondary outcomes

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	Diagnosis
Type of intervention	Other
Interventions/Control_1	administration of gadolimium contrast media
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	Adult patients with occulusive cerebrobascular disease scheduled for perfusuion MRI examination.
Key exclusion criteria	Patietns with a contraindication for the administration of gadolinium contrast media. Patients determinded to be ineligible to principal investigator.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Shigeki Middle name Last name Aoki
Organization	Juntendo University School of Medicine
Division name	Department of Radiology
Zip code	113-8421
Address	2-1-1 Hongo, Bunkyoku, Tokyo, 113-8421, Japan
TEL	+81-3-3813-3111
Email	saoki@juntendo.ac.jp

Public contact
Name of contact person	1st name Tomohiro Middle name Last name Takamura
Organization	Juntendo University School of Medicine
Division name	Department of Radiology
Zip code	113-8421
Address	211 Hongo Bunkyoku Tokyo Japan
TEL	03-3813-3111
Homepage URL
Email	t-takamura@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Juntendo University Hospital
Address	Hongo, Bunkyo-ku, Tokyo 2-1-1
Tel	03-3813-3111
Email	juntencrc@juntendo.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	2017 Year 09 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	37
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	Completed
Date of protocol fixation	2017 Year 07 Month 01 Day
Date of IRB	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 10 Day
Last follow-up date	2020 Year 06 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 31 Day
Last modified on	2021 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033102