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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023241
Receipt No. R000026782
Scientific Title Research on measurement methods of brain metabolites, glucose etc., using 7T-MRI
Date of disclosure of the study information 2016/08/01
Last modified on 2019/01/22

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Basic information
Public title Research on measurement methods of brain metabolites, glucose etc., using 7T-MRI
Acronym Research on measurement methods of brain metabolites using 7T-MRI
Scientific Title Research on measurement methods of brain metabolites, glucose etc., using 7T-MRI
Scientific Title:Acronym Research on measurement methods of brain metabolites using 7T-MRI
Region
Japan

Condition
Condition Normal volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate measurement methods of brain metabolites using Chemical Exchange Saturation Transfer imaging and MR spectroscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Agreement between blood metabolite levels and measured concentrations.
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
Device,equipment
Interventions/Control_1 Measure glucose concentration after administratoin of glucose. Other brain metabolites are also measured.
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 1. Healthy volunteers who gave written informed consent to this study.
Key exclusion criteria 1. Patients with diabetes mellitus.
2. Contra-indication to MRI examination.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohisa Okada
Organization Kyoto University
Division name Human Brain Research Center
Zip code
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto, JAPAN.
TEL 075-751-3760
Email tomokada@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Okada
Organization Kyoto University
Division name Human Brain Research Center
Zip code
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto, JAPAN.
TEL 075-751-3760
Homepage URL
Email tomokada@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization METI/JETRO
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
Address
Tel
Email

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 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Glucose concentration changes were observed in the brain using MRS after OGTT fluid intake per os.
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
Anticipated trial start date
2017 Year 01 Month 18 Day
Last follow-up date
Date of closure to data entry
2018 Year 11 Month 20 Day
Date trial data considered complete
2018 Year 11 Month 20 Day
Date analysis concluded
2018 Year 11 Month 20 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 20 Day
Last modified on
2019 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026782

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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