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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037495
Receipt No. R000042743
Scientific Title Development of MRI software for restricted diffusion-weighted imaging
Date of disclosure of the study information 2019/10/01
Last modified on 2020/08/07

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Basic information
Public title Development of MRI software for restricted diffusion-weighted imaging
Acronym MRI software for restricted diffusion-weighted imaging
Scientific Title Development of MRI software for restricted diffusion-weighted imaging
Scientific Title:Acronym MRI software for restricted diffusion-weighted imaging
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will develop MR software for restricted diffusion-weighted imaging.
Basic objectives2 Others
Basic objectives -Others We will use it for future clinical research.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Software completion
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 One MRI examination (about 30 minutes)
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Healthy medical radiologists who belong to medical institutions of research collaborators
2) Those who wish to participate in research voluntarily by understanding the significance of research
Key exclusion criteria 1) Healthy volunteer who has an internal implant device such as a cardiac pacemaker inserted
2) Healthy volunteer whose metal of unknown material exists in the body
3) Healthy volunteer who is a pregnant woman
Target sample size 2

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name Kuroda
Organization Graduate School of Health Sciences, Okayama University
Division name Radiological Technology
Zip code 7008558
Address 2-5-1 Shikata-cho, Okayama
TEL 086-235-6873
Email kurodamd@cc.okayama-u.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Kuroda
Organization Graduate School of Health Sciences, Okayama University
Division name Radiological Technology
Zip code 7008558
Address 2-5-1 Shikata-cho, Okayama
TEL 086-235-6873
Homepage URL
Email kurodamd@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1 Shikata-cho, Okayama
Tel 086-235-6938
Email mae6605@adm.okayama-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
2019 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications NA
Number of participants that the trial has enrolled 2
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
2019 Year 10 Month 01 Day
Date of IRB
2019 Year 12 Month 04 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2020 Year 08 Month 07 Day
Date of closure to data entry
2020 Year 08 Month 07 Day
Date trial data considered complete
2020 Year 08 Month 07 Day
Date analysis concluded
2020 Year 08 Month 07 Day

Other
Other related information

Management information
Registered date
2019 Year 07 Month 25 Day
Last modified on
2020 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042743

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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