UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010857
Receipt number 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 11:41:51

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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 or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



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

Value
https://center6.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