UMIN-CTR Clinical Trial

Basic information
Public title	Research on measurements of brain metabolites including glucose using 7T-MRI
Acronym	Research on measurements of brain metabolites using 7T-MRI
Scientific Title	Research on measurements of brain metabolites including glucose using 7T-MRI
Scientific Title:Acronym	Research on measurements of brain metabolites using 7T-MRI
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Research on measurement methods for brain metabolites using 7T-MRI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Agreementof blood glucose level and MR-measured glucose level.
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Data acquisition using a non-certified 7T-MRI system for clinical use.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Those who will participate in this study on his or her volunteer will and gave written informed consent.
Key exclusion criteria	DM patients under treatment and those who are contraindicated to MR examination checked with the pre-MRI check sheet.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Tomohisa Middle name Last name Okada
Organization	Kyoto University
Division name	Human Brain Research Center, Graduate School of Medicine
Zip code	606-8507
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL	0757513602
Email	tomokada@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Tomohisa Middle name Last name Okada
Organization	Kyoto University
Division name	Human Brain Research Center, Graduate School of Medicine
Zip code	606-8507
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL	0757513695
Homepage URL
Email	tomokada@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Human Brain Research Center, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Siemens Healthcare, K.K.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital Ethics Committee
Address	Yoshida Konoecho, Sakyoku, Kyoto
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	2017 Year 09 Month 07 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	Completed
Date of protocol fixation	2016 Year 11 Month 21 Day
Date of IRB	2018 Year 04 Month 12 Day
Anticipated trial start date	2017 Year 09 Month 07 Day
Last follow-up date	2018 Year 11 Month 18 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 11 Month 18 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 07 Day
Last modified on	2019 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033226