UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056439 |
|---|---|
| Receipt number | R000064492 |
| Scientific Title | 23Na-MRI brain research |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2024/12/12 16:46:28 |
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Basic information
Public title
23Na-MRI brain research
Acronym
23Na-MRI
Scientific Title
23Na-MRI brain research
Scientific Title:Acronym
23Na-MRI
Region
| Japan |
Condition
Condition
Healthy subjects, sleep disorders, brain tumors, cerebral infarction, cerebrovascular disease, dementia, neurodegenerative diseases, multiple sclerosis, epilepsy, psychiatric disorders
Classification by specialty
| Neurology | Psychiatry | Radiology |
| Neurosurgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Optimization of imaging conditions in 23Na-MRI for healthy research subjects. Differences in brain sodium content due to differences in age and sleep status in healthy subjects, and 23Na-MRI findings in patients and research subjects with brain tumors, cerebrovascular disorders, neurodegenerative diseases such as dementia, multiple sclerosis, epilepsy, and psychiatric disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scan time, signal-to-noise ratio, and reproducibility, and optimization of imaging protocol. Sodium distribution in each age group, sleeping situation, brain tumors, cerebral infarction, cerebrovascular disease, multiple sclerosis, epilepsy, dementia, psychiatric disorders.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects.
Subjects before and after the night shift.
Patients with brain tumors, stroke, cerebrovascular disease, dementia, neurodegenerative diseases, multiple sclerosis, epilepsy, and psychiatric disorders.
Key exclusion criteria
Poor general condition.
Claustrophobia.
Women who are considered to be in the early stages of pregnancy by their own admission and who plan to continue their pregnancy.
Subjects with metal or medical devices inserted that are not MR compatible
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nakamoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
6068507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3760
diag_rad@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Fushimi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
6068507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3760
Homepage URL
diag_rad@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2025 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Optimization of 23Na-MRI
Age, gender, brain segmentation using 3D T1 images, and image quality improvement by hostile generation network
(2) Sleep deprivation state
T1 value, T2 value, diffusion tensor image
(3) Various diseases (brain tumor, cerebral infarction, cerebrovascular disease, dementia, neurodegenerative disease, multiple sclerosis, epilepsy, psychiatric disease)
Clinical images (CT, MRI, PET, SPECT images, etc.), blood sampling data, cognitive function evaluation data, etc. taken at the same time.
Management information
Registered date
| 2024 | Year | 12 | Month | 12 | Day |
Last modified on
| 2024 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064492
