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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018534
Receipt No. R000021447
Scientific Title A study to develop a technique for measuring restricted diffusion and water permeability in vivo with a clinical MRI scanner
Date of disclosure of the study information 2015/08/10
Last modified on 2016/02/04

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Basic information
Public title A study to develop a technique for measuring restricted diffusion and water permeability in vivo with a clinical MRI scanner
Acronym Measuring restricted diffusion and water permeability by clinical MRI
Scientific Title A study to develop a technique for measuring restricted diffusion and water permeability in vivo with a clinical MRI scanner
Scientific Title:Acronym Measuring restricted diffusion and water permeability by clinical MRI
Region
Japan

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

Objectives
Narrative objectives1 To develop MRI scanning and image analyzing methods to measure restricted diffusion and water permeability in vivo.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Validity and reproducibility of the metrics. Robustness of the whole technique.
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 MRI scanning
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
40 years-old >
Gender Female
Key inclusion criteria Healthy female
Key exclusion criteria 1. history of severe systematic / CNS disease.
2. Drug and/or alcoholic abuse.
3. Not adaptable for MRI scanning (e.g. metallic devices, claustrophobia, nyctophobia)
4. Operator's decision as not suitable for this study.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiko Tachibana
Organization National Institute of Radiological Sciences
Division name Research Center for Charged Particle Therapy
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba
TEL 043-251-2111
Email ytachi@nirs.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiko Tachibana
Organization National Institute of Radiological Sciences
Division name Research center for Charged Particle Therapy
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba
TEL 043-251-2111
Homepage URL
Email ytachi@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National institute of radiological sciences
Organization
Division
Category of Funding 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
2015 Year 08 Month 10 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 Completed
Date of protocol fixation
2015 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 04 Day
Last modified on
2016 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021447

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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