UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Inquiry Search clinical trials

Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013179
Receipt No. R000015368
Scientific Title Comparative study of MP2RAGE vs. MPRAGE
Date of disclosure of the study information 2014/03/17
Last modified on 2017/02/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparative study of MP2RAGE vs. MPRAGE
Acronym MP2RAGE vs. MPRAGE
Scientific Title Comparative study of MP2RAGE vs. MPRAGE
Scientific Title:Acronym 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
1st name
Middle name
Last name Tomohisa Okada
Organization Kyoto University Graduate School of Medicine
Division name Diagnostic Imaging and Nuclear Medicine
Zip code
Address 54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL 075-751-3760
Email nmdioffice@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Okada
Organization Kyoto University Graduate School of Medicine
Division name Diagnostic Imaging and Nuclear Medicine
Zip code
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)

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
2014 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/26032895
Number of participants that the trial has enrolled
Results MP2RAGE has shown superior reproducibility of deep gray matter segmentation than MPRAGE.
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
2014 Year 02 Month 17 Day
Date of IRB
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

Other
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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015368

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.