UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020138 |
|---|---|
| Receipt number | R000023093 |
| Scientific Title | Study on 11C-ITMM accumlation in epileptic foci |
| Date of disclosure of the study information | 2015/12/10 |
| Last modified on | 2019/12/12 19:21:10 |
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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
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
ishii@pet.tmig.or.jp
Sponsor or person
Institute
Tokoyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023093
