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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005273
Receipt No. R000006215
Scientific Title The usefulness of 11C-flumazenil PET in patients with mesial temporal lobe epilepsy
Date of disclosure of the study information 2011/03/19
Last modified on 2014/10/26

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Basic information
Public title The usefulness of 11C-flumazenil PET in patients with mesial temporal lobe epilepsy
Acronym The usefulness of 11C-flumazenil PET in patients with mesial temporal lobe epilepsy
Scientific Title The usefulness of 11C-flumazenil PET in patients with mesial temporal lobe epilepsy
Scientific Title:Acronym The usefulness of 11C-flumazenil PET in patients with mesial temporal lobe epilepsy
Region
Japan

Condition
Condition mesial temporal lobe epilepsy
Classification by specialty
Neurology Pediatrics Psychiatry
Radiology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To demonstrate the usefulness of 11C-flumazenil PET in patients with mesial temporal lobe epilepsy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To demonstrate the usefulness of 11C-flumazenil PET in patients with mesial temporal lobe epilepsy
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
10 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria patients with intractable mesial temporal lobe epilepsy
Key exclusion criteria patients that their epileptic foci are clealy known
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Komoto
Organization Hiroshima University
Division name Department of Diagnostic Radiology
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hiroshima University
Division name Department of Diagnostic Radiology
Zip code
Address
TEL 082-257-5257
Homepage URL
Email

Sponsor
Institute Hiroshima University
Institute
Department

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
Email

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
2011 Year 03 Month 19 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
2011 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2011 Year 03 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 prospective study

Management information
Registered date
2011 Year 03 Month 18 Day
Last modified on
2014 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006215

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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