UMIN-CTR Clinical Trial

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
Email	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
Email	akane@med.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University, School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028852