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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025117
Receipt No. R000028878
Scientific Title Tuning up parameters in newly-developed MRI sequences_2
Date of disclosure of the study information 2016/12/25
Last modified on 2018/12/25

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Basic information
Public title Tuning up parameters in newly-developed MRI sequences_2
Acronym Tuning up parameters in MRI sequences
Scientific Title Tuning up parameters in newly-developed MRI sequences_2
Scientific Title:Acronym Tuning up parameters in MRI sequences
Region
Japan

Condition
Condition Healthy young people
Classification by specialty
Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To adjust imaging parameters for newly-developed the body MRI sequences.
Basic objectives2 Others
Basic objectives -Others To evaluate the image quality
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To find optimized imaging parameters.
Key secondary outcomes To evaluate the image quality.

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 Changing imaging parameters.
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
35 years-old >=
Gender Male and Female
Key inclusion criteria Healthy volunteers
Key exclusion criteria 1. Pregnancy or suggestive of pregnancy.
2. Implanted electrical or mechanical device in the body.
3. Claustrophobia
4. There are non-compliant items in the questionnaires.
5. A participant on any other clinical study.
6. Person who is ruled unfit to be a participant in this study.

Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Okuda
Organization Keio University School of Medicine
Division name Department of Diagnostic Radiology
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 03-3225-5715
Email okuda@rad.med.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeo Okuda
Organization Keio University School of Medicine
Division name Department of Diagnostic Radiology
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 03-3225-5715
Homepage URL
Email okuda@rad.med.keio.ac.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization GE Healthcare Japan
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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 25 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
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 12 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 19 Day
Last follow-up date
2018 Year 12 Month 25 Day
Date of closure to data entry
2018 Year 12 Month 25 Day
Date trial data considered complete
2018 Year 12 Month 25 Day
Date analysis concluded
2018 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 02 Day
Last modified on
2018 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028878

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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