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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028415
Receipt No. R000032484
Scientific Title Image analysis of brain imaging by using Olea workstation
Date of disclosure of the study information 2017/09/01
Last modified on 2017/07/27

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Basic information
Public title Image analysis of brain imaging by using Olea workstation
Acronym Olea brain
Scientific Title Image analysis of brain imaging by using Olea workstation
Scientific Title:Acronym Olea brain
Region
Japan

Condition
Condition Brain tumors, dementia, neurodegenerative disease
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Brain perfusion, segmentation, texture analysis and machine learning will be performed by using Olea workstation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual assessment of image analysis results.
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
0 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Healthy volunteers and patients who underwent cerebral perfusion and structure images.
Key exclusion criteria those with poor image quality, those who opt out of the registry.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kaori Togashi
Organization Kyoto University Hospital
Division name Radiology
Zip code
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL 075-751-3419
Email nmdioffice@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mari Yoshii
Organization Kyoto University Hospital
Division name Radiology
Zip code
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL 0757513419
Homepage URL
Email nmdioffice@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Toshiba Medical Systems Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Brain perfusion images and structure images will be analysed on the workstation.

Management information
Registered date
2017 Year 07 Month 27 Day
Last modified on
2017 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032484

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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