UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050419 |
|---|---|
| Receipt number | R000056434 |
| Scientific Title | Evaluation of test-retest reproducibility in diffusion tensor MR imaging with field monitoring |
| Date of disclosure of the study information | 2023/02/24 |
| Last modified on | 2024/03/01 18:11:49 |
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Basic information
Public title
Evaluation of test-retest reproducibility in diffusion tensor MR imaging with field monitoring
Acronym
Evaluation of test-retest reproducibility in diffusion tensor MR imaging with field monitoring
Scientific Title
Evaluation of test-retest reproducibility in diffusion tensor MR imaging with field monitoring
Scientific Title:Acronym
Evaluation of test-retest reproducibility in diffusion tensor MR imaging with field monitoring
Region
| Japan |
Condition
Condition
Normal brain
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test a field monitoring system through evaluating the test-retest reproducibility of parameters in diffusion tensor MR imaging
Basic objectives2
Others
Basic objectives -Others
performance test
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fractional anisotropy (FA)
Key secondary outcomes
Mean diffusivity (MD); axial diffusivity (AD); radial diffusivity (RD); and brain anatomy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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 examinations for healthy individuals
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Twenty- to sixty-year-old healthy individual
Key exclusion criteria
1)Individuals who may consent for participation in this study under duress.
2)Those who have a ferromagnetic metal item in their body.
3)Those who have claustrophobia
4)Those who have tattoos
5)Pregnant woman
6)Those who have neurological disorders
7)Those who have cognitive impairment
8)Those who have psychological disorders including depression, schizophrenia, and bipolar disorder
9)Those whom physicians have judged inappropriate for participation in this research study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tatsushi |
| Middle name | |
| Last name | Kobayashi |
Organization
National Cancer Center Hospital East
Division name
Department of Diagnostic Radiology
Zip code
277-8577
Address
Kashiwanoha 6-5-1, Kashiwa
TEL
0471331111
takobaya@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Yamaguchi |
Organization
National Cancer Center Hospital East
Division name
Department of Diagnostic Radiology
Zip code
277-8577
Address
Kashiwanoha 6-5-1, Kashiwa
TEL
0471331111
Homepage URL
masyamag@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Canon Medical Systems
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Canon Medical Systems
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center IRB
Address
Tsukiji 5-1-1, Tokyo
Tel
0335422511
irst@ml.res.ncc.go.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
| 2023 | Year | 02 | Month | 24 | 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
30
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 24 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056434
