UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016499 |
|---|---|
| Receipt number | R000019159 |
| Scientific Title | Research for network of brain function by using 3T MRI |
| Date of disclosure of the study information | 2015/02/12 |
| Last modified on | 2015/08/10 16:14:46 |
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Basic information
Public title
Research for network of brain function by using 3T MRI
Acronym
Research for network of brain function by using 3T MRI
Scientific Title
Research for network of brain function by using 3T MRI
Scientific Title:Acronym
Research for network of brain function by using 3T MRI
Region
| Japan |
Condition
Condition
Brain tumor, Epilepsy, cerebrovascular disease
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To research the change of the network of brain function under general anesthesia
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analyze preoperative, intraoperative, and postoperative MR images and evaluate the change of the network of brain function
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients of pre-operation or post-operation
Key exclusion criteria
Unstable vital sign, Heart pacemakers, magnetic material or substance within body
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeharu Kunieda |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
54 Kawahara-cho Shogoin Sakyo-ku, Kyoto,
TEL
81-75-751-3459
kuny@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rika Inano |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
54 Kawahara-cho Shogoin Sakyo-ku, Kyoto,
TEL
81-75-751-3459
Homepage URL
inan@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C) 24592159
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 02 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
preOP
OP
post OP
Management information
Registered date
| 2015 | Year | 02 | Month | 10 | Day |
Last modified on
| 2015 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019159
