UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034287 |
|---|---|
| Receipt number | R000039048 |
| Scientific Title | Evaluation of aging changes of the magnetic susceptibility in the brain in healthy Japanese |
| Date of disclosure of the study information | 2018/09/27 |
| Last modified on | 2020/03/30 23:46:45 |
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Basic information
Public title
Evaluation of aging changes of the magnetic susceptibility in the brain in healthy Japanese
Acronym
Evaluation of the magnetic susceptibility in the brain in healthy Japanese
Scientific Title
Evaluation of aging changes of the magnetic susceptibility in the brain in healthy Japanese
Scientific Title:Acronym
Evaluation of the magnetic susceptibility in the brain in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Correlation of magnetic suceptibility using quantitative susceptibility mapping (QSM) and age in healthy Japanese
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of the local magnetic susceptibility in quantitative susceptibility mapping (QSM) and age
Key secondary outcomes
1) Correlation of the localbrain atrophy using T1 weighted image (T1WI) and magnetic susceptibility in QSM
2) Correlation of the local cerebral blood flow in arterial spin labelling (ASL) and magnetic susceptibility in QSM
3) Correlation of the local diffusion parameters in diffusion tensor image (DTI) magnetic susceptibility in QSM
4) Correlation of the various types of imaging parameters in quantitative parametrical mapping (QPM) and magnetic susceptibility in QSM
5) Correlation of the result of cognitive function test (MMSE, MOCA-J) and magnetic susceptibility in QSM
6) Correlation of the magnetic susceptibility in QSM between MRI machines
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) >20 and <90 years old
2) informed consent is obtained after detailed explanation
Key exclusion criteria
1) past history of central nervous system or neuropsychiatric disorder
2) metallic implant and other MRI contraindicated objects
3) claustrophobia
4) pregnant female (including possible case)
Target sample size
249
Research contact person
Name of lead principal investigator
| 1st name | Kudo |
| Middle name | |
| Last name | Kohsuke |
Organization
Hokkaido university hospital
Division name
Department of Diagnostic and Interventional Radiology
Zip code
060-8648
Address
Kita14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-7779
kkudo@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kudo |
| Middle name | |
| Last name | Kohsuke |
Organization
Hokkaido university hospital
Division name
Department of Diagnostic and Interventional Radiology
Zip code
060-8648
Address
Kita14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-7779
Homepage URL
kkudo@huhp.hokudai.ac.jp
Sponsor or person
Institute
Department of Diagnostic and Interventional Radiology, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address
kita14 nishi5, kita-ku, Sapporo, Hokkaido
Tel
011-706-7061
crjimu@huhp.hokudai.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
| 2018 | Year | 09 | Month | 27 | 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
144
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
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 07 | Month | 24 | Day |
Date analysis concluded
Other
Other related information
observation study. Performing tests of cognitive function and MRI exams for healthy Japanese.
Management information
Registered date
| 2018 | Year | 09 | Month | 27 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039048
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
