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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007253
Receipt No. R000008555
Scientific Title Evaluation for clinical utility of Advanced MR imaging
Date of disclosure of the study information 2012/02/10
Last modified on 2014/02/18

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Basic information
Public title Evaluation for clinical utility of Advanced MR imaging
Acronym Clinical utility of Advanced MRI
Scientific Title Evaluation for clinical utility of Advanced MR imaging
Scientific Title:Acronym Clinical utility of Advanced MRI
Region
Japan

Condition
Condition central nervous system disease
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 For the patient that CNS disease is suspected by a morphological diagnosis by MRI, we perform advanced MRI and evaluate for clinical utility.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We compare blood flow by advanced MRI with metabolic function by PET/SPECT, and review it about evaluation for CNS disease by advanced MRI.
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 No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 MRI
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 The patient that a central nervous system disease is suspected by a morphological diagnosis by MRI
Key exclusion criteria The patient who has metal such as pacemaker in the body, and cannot perform MRI examination
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Yamamoto
Organization University Of Fukui
Division name Department of Radiology
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL 0776613111
Email yamatatu@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Yamamoto
Organization University Of Fukui
Division name Department of Radiology
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL 0776-61-3111
Homepage URL
Email yamatatu@jichi.ac.jp

Sponsor
Institute University Of Fukui
Institute
Department

Funding Source
Organization University Of Fukui
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
2012 Year 02 Month 10 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 Enrolling by invitation
Date of protocol fixation
2010 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 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
2012 Year 02 Month 09 Day
Last modified on
2014 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008555

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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