UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025090 |
|---|---|
| Receipt number | R000028852 |
| Scientific Title | The clinical trial to evaluate the efficacy of [11C]K-2 in refractory epilepsy patients undergoing anterior temporal lobectomy |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2020/12/25 16:41:38 |
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Basic information
Public title
The clinical trial to evaluate the efficacy of [11C]K-2 in refractory epilepsy patients undergoing anterior temporal lobectomy
Acronym
The clinical trial to evaluate the efficacy of [11C]K-2 in epilepsy patients
Scientific Title
The clinical trial to evaluate the efficacy of [11C]K-2 in refractory epilepsy patients undergoing anterior temporal lobectomy
Scientific Title:Acronym
The clinical trial to evaluate the efficacy of [11C]K-2 in epilepsy patients
Region
| Japan |
Condition
Condition
refractory epilepsy patients
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the efficacy of [11C]K-2 in measuring the densities of AMPA receptors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation of the AMPA receptors densities examined by biochemical study and [11C]K-2 PET study
Key secondary outcomes
The adverse events occured in patients during 7days after PET scan
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
| Medicine |
Interventions/Control_1
The administration of PET tracer
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.refractory epilepsy patients(mesial temporal lobe epilepsy)
2.patinets for anterior temporal lobectomy(ATL)
3.patients who are without cerebral surgery on the same side of ATL
4.patients who are 20 years or older
5.patients who can consent to this study by oneself
Key exclusion criteria
1.patients who have significant abnormalities insides the brains
2.patients who have experienced the electric stimulation therapy
3.patients who undergo artificial dialysis
4.patients who have severe liver dysfunction
5.patients who have tatoo
6.claustrophobic patients
7.breast-feeding mothers, expecting mothers, females who desire to be a mother
8.patients who desire to bear a child within this study period
9.patients who take Fycompa
10.patients who underwent nuclear medicine examination within one-week before this registarion
11.patients who underwent other clinical trials using unapproved nuclear medicine examination within six month before this registarion
12.patients who underwent other clinical trials within 12 weeks before this registarion
13.patients whom study doctors consider unappropriate
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | miyazaki |
| Middle name | |
| Last name | tomoyuki |
Organization
Yokohama City University, School of Medicine
Division name
Department of Physiology
Zip code
236-0051
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2579
johney@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | sano |
| Middle name | |
| Last name | akane |
Organization
Yokohama City University, School of Medicine
Division name
Department of Physiology
Zip code
236-0051
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2579
Homepage URL
akane@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Certified Institutional Review Board
Address
3-9 Fukuura,kanazawa-ku,Yokohama,Kanagawa , Kanagawa
Tel
045-370-7627
rinri@yokohama-cu.ac.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
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
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
| 2016 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 30 | Day |
Last modified on
| 2020 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028852
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
