UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018669
Receipt number R000021549
Scientific Title A study of epilepsy with Methionine PET/CT
Date of disclosure of the study information 2015/08/14
Last modified on 2016/08/15 11:08:38

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Basic information

Public title

A study of epilepsy with Methionine PET/CT

Acronym

A study of epilepsy with Methionine PET/CT

Scientific Title

A study of epilepsy with Methionine PET/CT

Scientific Title:Acronym

A study of epilepsy with Methionine PET/CT

Region

Japan


Condition

Condition

epilepsy

Classification by specialty

Neurology Psychiatry Radiology
Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

cerebral blood flow and cerebral glucose metabolism is raised by neuronal activity. However there is no evidence to show the increase in amino acid metabolism by brain activation, and we think amino acid metabolism has no direct relationship with brain activation. However, we assume indirect relationships such as neurotransmitter synthesis or motor protein synthesis. We investigate whether focus of epilepsy accumulates C-11 methionine or not.
This Methionine PET can be useful clinically.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

methionine accumulation in the focus of epilepsy

Key secondary outcomes



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

Device,equipment

Interventions/Control_1

C-11 Methionine PET/CT

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

Key exclusion criteria

patients who do not agree to participate
patients who have difficulty in stopping moving
other patients whom researcher (doctor) judged to exclude.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masashi Kameyama

Organization

National Center for Global Health and Medicine

Division name

Division of Nuclear Medicine

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan, 162-8655

TEL

03-5273-6881

Email

kame-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masashi Kameyama

Organization

National Center for Global Health and Medicine

Division name

Division of Nuclear Medicine

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan, 162-8655

TEL

03-5273-6881

Homepage URL


Email

kame-tky@umin.ac.jp


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

Other

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

National Center for Global Health and Medicine


Other administrative information

Date of disclosure of the study information

2015 Year 08 Month 14 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

Terminated

Date of protocol fixation

2015 Year 02 Month 09 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 16 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 08 Month 14 Day

Last modified on

2016 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021549


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name