UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Construction of normal brain FDG-PET and MRI database useful for diagnosing epilepsy and other conditions
Title of the study (Brief title)	Construction of normal brain FDG-PET and MRI database
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Neurology Radiology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To construct brain FDG-PET and MRI database of healthy adults
Basic objectives2	Others
Basic objectives -Others	Acquisition of normal data
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To construct brain FDG-PET and MRI database of healthy adults
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adults who agree with this research
Key exclusion criteria	1 With a pacemaker 2 With any magnetic metal objects in a body 3 Unable to communicate with others 4 Bad physical status 5 Unable to agree this research 6 Pregnant woman 7 Smoker (more than 20 cigarettes a day for 20 years)
Target sample size	50

Research contact person
Name of lead principal investigator	Akio Ikeda
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Epilepsy, Movement Disorders and Physiology
Address	Kawahara-cho 54, Shogoin, Sakyo-ku
TEL	075-751-3662
Email	akio@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Tomohiko Murai
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Neurology
Address	Kawahara-cho 54, Shogoin, Sakyo-ku
TEL	075-751-3772
Homepage URL
Email	tmurai28@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
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)

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	京都大学病院（京都府）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 20 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2016 Year 02 Month 04 Day
Date of closure to data entry	2016 Year 02 Month 04 Day
Date trial data considered complete	2016 Year 02 Month 04 Day
Date analysis concluded	2016 Year 02 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To perform FDG-PET and MRI.

Management information
Registered date	2013 Year 12 Month 20 Day
Last modified on	2016 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014785