UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012643 |
|---|---|
| Receipt number | R000014785 |
| Scientific Title | Construction of normal brain FDG-PET and MRI database useful for diagnosing epilepsy and other conditions |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2016/12/26 22:49:38 |
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Basic information
Public title
Construction of normal brain FDG-PET and MRI database useful for diagnosing epilepsy and other conditions
Acronym
Construction of normal brain FDG-PET and MRI database
Scientific Title
Construction of normal brain FDG-PET and MRI database useful for diagnosing epilepsy and other conditions
Scientific Title:Acronym
Construction of normal brain FDG-PET and MRI database
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Neurology | Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct brain FDG-PET and MRI database of healthy adults
Basic objectives2
Others
Basic objectives -Others
Acquisition of normal data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To construct brain FDG-PET and MRI database of healthy adults
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who agree with this research
Key exclusion criteria
1 With a pacemaker
2 With any magnetic metal objects in a body
3 Unable to communicate with others
4 Bad physical status
5 Unable to agree this research
6 Pregnant woman
7 Smoker (more than 20 cigarettes a day for 20 years)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Ikeda |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Epilepsy, Movement Disorders and Physiology
Zip code
Address
Kawahara-cho 54, Shogoin, Sakyo-ku
TEL
075-751-3662
akio@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Murai |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Neurology
Zip code
Address
Kawahara-cho 54, Shogoin, Sakyo-ku
TEL
075-751-3772
Homepage URL
tmurai28@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
京都大学病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2014 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 04 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 04 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 04 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 04 | Day |
Other
Other related information
To perform FDG-PET and MRI.
Management information
Registered date
| 2013 | Year | 12 | Month | 20 | Day |
Last modified on
| 2016 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014785
