UMIN-CTR Clinical Trial

Basic information
Public title	Study on 11C-ITMM accumlation in epileptic foci
Acronym	11C-ITMM PET in epilepsy
Scientific Title	Study on 11C-ITMM accumlation in epileptic foci
Scientific Title:Acronym	11C-ITMM PET in epilepsy
Region	Japan

Condition
Condition	partial epilepsy
Classification by specialty	Neurology Radiology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation on accumulation of C-11 ITMM in epileptic foci
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Distribution of C-11 ITMM in epileptic foci Date of evaluation: on the day of PET scan
Key secondary outcomes	Distribution of C-11 flumazenil in epileptic foci Date of evaluation: on the day of PET scan

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	The dosage in the vain of [C-11]ITMM for PET/CT imaging.
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	18 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients diagnosed as having epilepsy. 2. Parients being suspected of partial seizure based on seizure symptoms, brain MRI and FDG-PET findings. 3. Patients with documented agreement on the informed consent by themselves or by their legally acceptable representatives.
Key exclusion criteria	1. Patients who are suspected of generalized seizure. 2. Patients accompanied by chronic renal failure. 3. Pregnant women or possible pregnant women. 4. The patient who judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kenji Middle name Last name Ishii
Organization	Tokoyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Zip code	173-0015
Address	35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL	03-3964-3241
Email	ishii@pet.tmig.or.jp

Public contact
Name of contact person	1st name Kenji Middle name Last name Ishii
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Research Team for Neuroimaging
Zip code	173-0015
Address	Itabashi-ku
TEL	03-3964-3241
Homepage URL
Email	ishii@pet.tmig.or.jp

Sponsor
Institute	Tokoyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization	Tokoyo Metropolitan Institute of Gerontology
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee, Tokyo Metropolitan Institute of Gerontology
Address	35-2 Sakaecyo, Itabashi-ku, Tokyo, Japan
Tel	03-3964-3241
Email	naomi_hasegawa@tmghig.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	地方独立行政法人東京都健康長寿医療センター研究所

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 10 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	2015 Year 10 Month 14 Day
Date of IRB	2017 Year 06 Month 25 Day
Anticipated trial start date	2015 Year 12 Month 21 Day
Last follow-up date	2019 Year 03 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	2015 Year 12 Month 09 Day
Last modified on	2019 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023093