UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012896
Receipt number R000015067
Scientific Title Evaluation of Oxygen Enhanced MRI
Date of disclosure of the study information 2014/02/01
Last modified on 2020/05/09 12:11:36

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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 or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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