UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of MP2RAGE vs. MPRAGE
Title of the study (Brief title)	MP2RAGE vs. MPRAGE
Region	Japan

Condition
Condition	Normal volunteers
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate reproducibility of MP2RAGE compared to MPRAGE and superiority of the former scan method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reproducibility of MP2RAGE compared to MPRAGE.
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	A pair of MP2RAGE scans will be conducted for every healthy subjects. Age-related changes in T1 values are also investigated.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy subjects are selected by absence of previous clinical history at departments of neurosurgery, neurology or psychiatry.
Key exclusion criteria	Subjects incompatible to MRI scan.
Target sample size	100

Research contact person
Name of lead principal investigator	Tomohisa Okada
Organization	Kyoto University Graduate School of Medicine
Division name	Diagnostic Imaging and Nuclear Medicine
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL	075-751-3760
Email	nmdioffice@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Tomohisa Okada
Organization	Kyoto University Graduate School of Medicine
Division name	Diagnostic Imaging and Nuclear Medicine
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL	075-751-3760
Homepage URL
Email	nmdioffice@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	KibanKenkyu C, Japan Science and Technology Agency.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

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

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 17 Day
Anticipated trial start date	2014 Year 03 Month 17 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 01 Month 01 Day
Date analysis concluded	2017 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/26032895
Results	MP2RAGE has shown superior reproducibility of deep gray matter segmentation than MPRAGE.
Other related information

Management information
Registered date	2014 Year 02 Month 17 Day
Last modified on	2017 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015368