UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014137 |
|---|---|
| Receipt number | R000016464 |
| Scientific Title | A study of a method to calculate diffusional kurtosis image with anisotropy |
| Date of disclosure of the study information | 2014/06/02 |
| Last modified on | 2016/02/04 17:33:10 |
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Basic information
Public title
A study of a method to calculate diffusional kurtosis image with anisotropy
Acronym
A study of a method to calculate diffusional kurtosis image with anisotropy
Scientific Title
A study of a method to calculate diffusional kurtosis image with anisotropy
Scientific Title:Acronym
A study of a method to calculate diffusional kurtosis image with anisotropy
Region
| Japan |
Condition
Condition
Healthy woman volunteers
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a method to obtain practical diffusional kurtosis image with anisotropy from a clinical data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the new methods with the conventional one regarding the quality, the appropriateness of the images, and also the robustness of the calculation.
Key secondary outcomes
Base
Study type
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
| Other |
Interventions/Control_1
examination
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
Healty volunteers
Key exclusion criteria
Current of past history of systemic diseases and brain diseases
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Obata |
Organization
National institute of radiological sciences
Division name
Research center for charged particle therapy
Zip code
Address
Chiba-ken Chiba-shi Anagawa 4-9-1
TEL
043-251-2111
t_obata@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
Chiba-ken Chiba-shi Anagawa 4-9-1
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
| 2014 | Year | 06 | Month | 02 | 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
| 2014 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 07 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 02 | 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=R000016464
