UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018534 |
|---|---|
| Receipt number | 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 17:32:24 |
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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
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
ytachi@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021447
