UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018781 |
|---|---|
| Receipt number | R000021725 |
| Scientific Title | Intraoperative Cerebral Blood Flow and Metabolism Measurement using Intraoperative MRI |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2016/08/26 14:47:49 |
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Basic information
Public title
Intraoperative Cerebral Blood Flow and Metabolism Measurement using Intraoperative MRI
Acronym
Intraoperative Cerebral Blood Flow and Metabolism Measurement using Intraoperative MRI
Scientific Title
Intraoperative Cerebral Blood Flow and Metabolism Measurement using Intraoperative MRI
Scientific Title:Acronym
Intraoperative Cerebral Blood Flow and Metabolism Measurement using Intraoperative MRI
Region
| Japan |
Condition
Condition
Patients undergoing cranial neurosurgery with intraoperative MRI
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Intraoperative cerebral blood flow and metabolism measurement using intraoperative MRI
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BOLD signal recorded by intraoperative 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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
intraoperative MRI
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 meet all of the requirements described bellow are included.
1. Patients who undergo cranial neurosurgery with intraoperative MRI.
2. Patients who provide a wittern informed consent.
Key exclusion criteria
Patients who meet any of the conditions described bellow are excluded.
1. Patients who can not undertake MRI.
2. Patients who are judged inappropriate by the doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Kohta |
Organization
Kobe university hospital
Division name
Neurosurgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5966
kohta@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Kohta |
Organization
Kobe university hospital
Division name
Neurosurgery
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5966
Homepage URL
kohta@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 24 | Day |
Last modified on
| 2016 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021725
