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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012896
Receipt No. R000015067
Scientific Title Evaluation of Oxygen Enhanced MRI
Date of disclosure of the study information 2014/02/01
Last modified on 2020/05/09

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Basic information
Public title Evaluation of Oxygen Enhanced MRI
Acronym Oxygen Enhanced MRI
Scientific Title Evaluation of Oxygen Enhanced MRI
Scientific Title:Acronym Oxygen Enhanced MRI
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to obtain T1 value of CSF after inhalation of oxygen. Sequential change will be evaluated and optimization of MR imaging will be perfomed.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes After inhalation of oxygen
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 oxygen inhalation
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

Not applicable
Gender Male and Female
Key inclusion criteria healthy volunteer
Key exclusion criteria subjects who are not applicable for MR scan.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yasutaka
Middle name
Last name Fushimi
Organization Kyoto University Graduate School of Medicine
Division name Department of Diagnostic Imaging and Nuclear Medicine
Zip code 6068507
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL 075-751-3760
Email nmdi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Yasutaka
Middle name
Last name Yasutaka Fushimi
Organization Kyoto University Graduate School of Medicine
Division name Department of Diagnostic Imaging and Nuclear Medicine
Zip code 6068507
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL 075-751-3760
Homepage URL
Email yfushimi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization NA
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 Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel 075-753-4680
Email ethcom@kuhp.kyoto-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
2014 Year 02 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 Open public recruiting
Date of protocol fixation
2014 Year 02 Month 01 Day
Date of IRB
2014 Year 02 Month 13 Day
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
2021 Year 02 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 19 Day
Last modified on
2020 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015067

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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