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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002766
Receipt No. R000003350
Scientific Title Establishment of normal data base of brain MRI
Date of disclosure of the study information 2009/11/16
Last modified on 2013/11/21

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Basic information
Public title Establishment of normal data base of brain MRI
Acronym Establishment of normal data base of brain MRI
Scientific Title Establishment of normal data base of brain MRI
Scientific Title:Acronym Establishment of normal data base of brain MRI
Region
Japan

Condition
Condition Degenerative and psychiatric disorder of the brain
Classification by specialty
Neurology Psychiatry Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to establish and verify the MRI-database of normal brain for statistical image analysis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Statistical evalation of distribution of image data from the current MRI indices including diffusion anisotropy and regional volume loss.
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 Diagnosis by MR imaging including diffusion tensor imaging and high-resolusion imaging.
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
15 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who have no neurologic symptoms and disorders
Key exclusion criteria Patients who will be in the status that examination can be undergone, and those who refused examination.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junya Konishi
Organization Kobe University
Division name Department of Radiology
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Junya Konishi
Organization Kobe University
Division name Department of Radiology
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
Homepage URL
Email

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2009 Year 11 Month 16 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 Terminated
Date of protocol fixation
2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 15 Day
Last modified on
2013 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003350

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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