UMIN-CTR Clinical Trial

Basic information
Public title	Integrated Brain Research of Brain Structures, Blood Flow, and Function.
Acronym	Integrated Brain Research
Scientific Title	Integrated Brain Research of Brain Structures, Blood Flow, and Function.
Scientific Title:Acronym	Integrated Brain Research
Region	Japan

Condition
Condition	healthy volunteer, neurodegenerative disease, brain infarction, high risk factors of brain infarction, moyamoya disease, and brain tumors
Classification by specialty	Neurology Radiology Neurosurgery Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To validate the imaging sequences and postproscessing method of structures, cerebral blood flow, and MR spectroscopy by comparing healthy volunteers with patients,
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	quantitative data deprived from imaging sequences and postproscessing analysis.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy volunteer, neurodegenerative disease, brain infarction, high risk of brain infarction, moyamoya disease, brain tumor
Key exclusion criteria	metalic device inside the body,communication disorder, poor general condition, subjects who are supposed to be unsuitable for this study.
Target sample size	225

Research contact person
Name of lead principal investigator	1st name Yasutaka Middle name Last name Fushimi
Organization	Kyoto University Graduate School of Medicine,
Division name	Department of Diagnostic Imaging and Nuclear Medicine
Zip code	6068507
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto,
TEL	81-75-751-3760
Email	nmdioffice@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Yasutaka Middle name Last name Fushimi
Organization	Kyoto University Graduate School of Medicine,
Division name	Department of Diagnostic Imaging and Nuclear Medicine
Zip code	6068507
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto,
TEL	81-75-751-3760
Homepage URL
Email	nmdioffice@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-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	2014 Year 12 Month 25 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	2014 Year 12 Month 10 Day
Date of IRB	2015 Year 01 Month 23 Day
Anticipated trial start date	2015 Year 01 Month 10 Day
Last follow-up date	2025 Year 01 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Brain structure, perfusion and function will be evaluated on MRI.

Management information
Registered date	2014 Year 12 Month 09 Day
Last modified on	2020 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018316