UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058024 |
|---|---|
| Receipt number | R000066324 |
| Scientific Title | Development of Generative AI Technologies for Clinical Applications Using 7-Tesla MRI |
| Date of disclosure of the study information | 2025/05/30 |
| Last modified on | 2025/05/30 13:59:59 |
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Basic information
Public title
GAIN-7T Study: Generative AI for Imaging in Neuropsychiatric Disorders with 7-Tesla MRI
Acronym
GAIN-7T Study
Scientific Title
Development of Generative AI Technologies for Clinical Applications Using 7-Tesla MRI
Scientific Title:Acronym
GAIN-7T Study
Region
| Japan |
Condition
Condition
Cases with suspected structural or functional brain abnormalities, as well as healthy controls for comparison.
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop generative AI-based technologies for 7T-MRI, including denoising, super-resolution, image-to-image translation, and high-resolution spatiotemporal imaging, with potential applications in neuropsychiatric disorders.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to evaluate the utility of generative AI in 7T-MRI for neuropsychiatric disorders.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Similarity between generated MRI and original MRI
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurements will include 7T-MRI, 3T-MRI, and neuropsychological assessments.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients: Males and females aged 18 to under 90 years with suspected structural or functional brain abnormalities based on clinical evaluation by psychiatrists, neurologists, or neurosurgeons.
2. Healthy controls: Males and females aged 18 to under 90 years with no abnormalities in the central nervous system.
Key exclusion criteria
1. Patients: Individuals with impaired consciousness, difficulty in independent walking, or those whose condition is expected to deteriorate. Also excluded are those deemed unsuitable for MRI based on the MRI Pre-screening Checklist.
2. Healthy controls: Individuals deemed unsuitable for MRI based on the MRI Pre-screening Checklist.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Oishi |
Organization
Kyoto University Graduate School of Medicine
Division name
Human Brain Research Center
Zip code
606-8507
Address
Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3695
noishi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Oishi |
Organization
Kyoto University Graduate School of Medicine
Division name
Human Brain Research Center
Zip code
606-8507
Address
Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3695
Homepage URL
noishi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-366-7618
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 | 05 | Month | 30 | 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
| 2025 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2025 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066324
