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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010857
Receipt No. R000012709
Scientific Title Usefulness of 11C Methionine PET in patients with epilepsy or brain tumor
Date of disclosure of the study information 2013/06/20
Last modified on 2015/06/02

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Basic information
Public title Usefulness of 11C Methionine PET in patients with epilepsy or brain tumor
Acronym 11C Methionine PET in epilepsy or brain tumor
Scientific Title Usefulness of 11C Methionine PET in patients with epilepsy or brain tumor
Scientific Title:Acronym 11C Methionine PET in epilepsy or brain tumor
Region
Japan

Condition
Condition epilepsy, brain tumor
Classification by specialty
Pediatrics Psychiatry Radiology
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify diagnostic and clinical usefulness of 11C methionine PET in patients with epilepsy or brain tumor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pathological findings
Key secondary outcomes Sensitivity of 11C methionine PET

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 Device,equipment
Interventions/Control_1 11C methionine PET
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with epilepsy
Patients with brain tumor
Key exclusion criteria 1. Persons with severe physical conditions
2. Expecting mother at PET examination
3. Persons with contraindications of MRI or PET
4. Inadequate persons decided by medical doctors
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimiteru Ito
Organization Tokyo Metropolitan Geriatric Hospital
Division name Radiology
Zip code
Address 35-3 Sakae-cho Itabashi-ku Tokyo
TEL 03-3964-1141
Email kimiteru_ito@tmghig.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Matsuda
Organization National Center of Neurology and Psychiatry
Division name Integrative Brain Imaging Center
Zip code
Address 4-1-1 Ogawahigashi-cho, Kodaira, Tokyo
TEL 042-341-2094
Homepage URL
Email matsudah@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2013 Year 06 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Refer the following paper.
Evaluation of amygdala pathology using (11)C-methionine positron emission tomography/computed tomography in patients with temporal lobe epilepsy and amygdala enlargement.
Sone D, Ito K, Taniguchi G, Murata Y, Nakata Y, Watanabe Y, Okazaki M, Sato N, Matsuda H, Watanabe M.
Epilepsy Res. 2015 May;112:114-21. doi: 10.1016/j.eplepsyres.2015.02.018. Epub 2015 Mar 10.
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 07 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 05 Day
Last follow-up date
2014 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 06 Month 02 Day
Last modified on
2015 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012709

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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