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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015022
Receipt No. R000017474
Scientific Title Intravoxel incoherent motion diffusion weighted MRI in the classification of brain tumors
Date of disclosure of the study information 2014/09/02
Last modified on 2017/09/05

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Basic information
Public title Intravoxel incoherent motion diffusion weighted MRI in the classification of brain tumors
Acronym IVIM imaging in brain tumors
Scientific Title Intravoxel incoherent motion diffusion weighted MRI in the classification of brain tumors
Scientific Title:Acronym IVIM imaging in brain tumors
Region
Japan

Condition
Condition brain tumor
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the diagnostic performance of intravoxel incoherent motion (IVIM) MR imaging in brain tumors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Perfusion fraction (f)
Diffusion coefficient (D)
Key secondary outcomes WHO grade
MIB-1 index
VEGF
CD31

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Brain tumor is suspected, the patient to undergo MRI as a part of the preoperative examination

Written informed consent is obtained.

Key exclusion criteria Patients who have a heart pacemaker, cochlear implant, metallic foreign body, metallic devices

Patients with severe claustrophobia

Pregnancy

Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Honda
Organization Departments of Clinical Radiology,
Graduate School of Medical Sciences, Kyushu University
Division name Clinical Radiology
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL +81926425695
Email yamakou@radiol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Yamashita
Organization Departments of Clinical Radiology, Graduate School of Medical Sciences, Kyushu University
Division name Clinical Radiology
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL +81926425695
Homepage URL
Email yamakou@radiol.med.kyushu-u.ac.jp

Sponsor
Institute Department of Clinical Radiology,
Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
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 09 Month 02 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 Completed
Date of protocol fixation
2014 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 02 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 08 Month 31 Day

Other
Other related information Prospective

Management information
Registered date
2014 Year 09 Month 02 Day
Last modified on
2017 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017474

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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