UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quantitative measurement of cerebral blood flow by NIRS
Title of the study (Brief title)	Quantitative measurement of cerebral blood flow by NIRS
Region	Japan

Condition
Condition	Cerebral blood vessel disease
Classification by specialty	Laboratory medicine Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is the erection of the quantitative measurement of cerebral blood flow by NIRS
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the erection of the quantitative measurement of cerebral blood flow by NIRS
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	Prevention
Type of intervention	Medicine
Interventions/Control_1	ICG injection
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	Indication of PET or SPECT Over 20 years old
Key exclusion criteria	It is impossible to obtain the consent allergy of ICG or iodine scar in the scalp
Target sample size	30

Research contact person
Name of lead principal investigator	Ohnishi Yoshihiko
Organization	National cerebral and cardiovascular center
Division name	Department of Anesthesiology
Address	Fujishirodai 5-7-1, Suita, Osaka
TEL	06-6833-5012
Email	yonishi@hotmail.co.jp

Public contact
Name of contact person	Shinya Kato
Organization	National Cerebral and Cardiovascular center
Division name	Department of Anesthesiology
Address	Fujishirodai 5-7-1, Suita, Osaka
TEL	06-6833-5012
Homepage URL
Email	numberboy1122@yahoo.co.jp

Sponsor
Institute	National Cerebral and Cardiovascular center
Institute
Department

Funding Source
Organization	Ministry of Education Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	2016 Year 06 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

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Publication of results	Unpublished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

Management information
Registered date	2016 Year 06 Month 19 Day
Last modified on	2017 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022032