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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034287
Receipt No. R000039048
Scientific Title Evaluation of aging changes of the magnetic susceptibility in the brain in healthy Japanese
Date of disclosure of the study information 2018/09/27
Last modified on 2019/06/15

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Basic information
Public title Evaluation of aging changes of the magnetic susceptibility in the brain in healthy Japanese
Acronym Evaluation of the magnetic susceptibility in the brain in healthy Japanese
Scientific Title Evaluation of aging changes of the magnetic susceptibility in the brain in healthy Japanese
Scientific Title:Acronym Evaluation of the magnetic susceptibility in the brain in healthy Japanese
Region
Japan

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

Objectives
Narrative objectives1 Correlation of magnetic suceptibility using quantitative susceptibility mapping (QSM) and age in healthy Japanese
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation of the local magnetic susceptibility in quantitative susceptibility mapping (QSM) and age
Key secondary outcomes 1) Correlation of the localbrain atrophy using T1 weighted image (T1WI) and magnetic susceptibility in QSM
2) Correlation of the local cerebral blood flow in arterial spin labelling (ASL) and magnetic susceptibility in QSM
3) Correlation of the local diffusion parameters in diffusion tensor image (DTI) magnetic susceptibility in QSM
4) Correlation of the various types of imaging parameters in quantitative parametrical mapping (QPM) and magnetic susceptibility in QSM
5) Correlation of the result of cognitive function test (MMSE, MOCA-J) and magnetic susceptibility in QSM
6) Correlation of the magnetic susceptibility in QSM between MRI machines

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
90 years-old >
Gender Male and Female
Key inclusion criteria 1) >20 and <90 years old
2) informed consent is obtained after detailed explanation
Key exclusion criteria 1) past history of central nervous system or neuropsychiatric disorder
2) metallic implant and other MRI contraindicated objects
3) claustrophobia
4) pregnant female (including possible case)
Target sample size 249

Research contact person
Name of lead principal investigator
1st name Kudo
Middle name
Last name Kohsuke
Organization Hokkaido university hospital
Division name Department of Diagnostic and Interventional Radiology
Zip code 060-8648
Address Kita14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL 011-706-7779
Email kkudo@huhp.hokudai.ac.jp

Public contact
Name of contact person
1st name Kudo
Middle name
Last name Kohsuke
Organization Hokkaido university hospital
Division name Department of Diagnostic and Interventional Radiology
Zip code 060-8648
Address Kita14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL 011-706-7779
Homepage URL
Email kkudo@huhp.hokudai.ac.jp

Sponsor
Institute Department of Diagnostic and Interventional Radiology, Hokkaido University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address kita14 nishi5, kita-ku, Sapporo, Hokkaido
Tel 011-706-7061
Email crjimu@huhp.hokudai.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
2018 Year 09 Month 27 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
2017 Year 03 Month 08 Day
Date of IRB
2017 Year 03 Month 08 Day
Anticipated trial start date
2017 Year 03 Month 08 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observation study. Performing tests of cognitive function and MRI exams for healthy Japanese.

Management information
Registered date
2018 Year 09 Month 27 Day
Last modified on
2019 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039048

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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