UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048705 |
|---|---|
| Receipt number | R000055496 |
| Scientific Title | Epileptic focus identification by MEG and PET for MRI-negative refractory epilepsy |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2025/02/18 16:02:11 |
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Basic information
Public title
Epileptic focus identification by MEG and PET for MRI-negative refractory epilepsy
Acronym
Epileptic focus identification by MEG and PET for MRI-negative refractory epilepsy
Scientific Title
Epileptic focus identification by MEG and PET for MRI-negative refractory epilepsy
Scientific Title:Acronym
Epileptic focus identification by MEG and PET for MRI-negative refractory epilepsy
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of FDG-PET and MEG-based diagnosis of epilepsy foci in patients with MRI-negative refractory epilepsy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic reliability of the developed method
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent epilepsy surgery at Tokyo University hospital from April 1, 2013 to June 30, 2022, were followed up for more than 1 year, and for which clinical data were available.
Key exclusion criteria
Patients or his/her proxy who refuses to use the data for this research by December 31, 2022.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miwako |
| Middle name | |
| Last name | Takahashi |
Organization
National Institutes for Quantum Science and Technology (QST)
Division name
Institute for Quantum Medical Science
Zip code
263-8555
Address
Chiba city, Inage-ku, 4-9-1
TEL
043-206-3260
takahashi.miwako@qst.go.jp
Public contact
Name of contact person
| 1st name | Miwako |
| Middle name | |
| Last name | Takahashi |
Organization
National Institutes for Quantum Science and Technology (QST)
Division name
Institute for Quantum Medical Science
Zip code
263-8555
Address
Chiba city, Inage-ku, 4-9-1
TEL
043-206-3260
Homepage URL
takahashi.miwako@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology (QST)
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology Certified Review Board
Address
Chiba city, Inage-ku, 4-9-1
Tel
043-206-4706
helsinki@qst.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
| 2022 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Retrospectively collected data are divided into two groups, MRI-negative and MRI-positive. The surgical area is the standard of truth.
2) FDG-PET images with MRI-negative and with MRI-positive, and FDG decreased area and MEG dipole distribution are compared.
3) About 20% of cases of the MRI-negative group are randomly extracted for verification. The rest cases are used for development of diagnostic method.
4) The developed diagnostic method is tested using the verification cases.
Management information
Registered date
| 2022 | Year | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055496
