UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intravoxel incoherent motion diffusion weighted MRI in the classification of brain tumors
Title of the study (Brief title)	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	Hiroshi Honda
Organization	Departments of Clinical Radiology, Graduate School of Medical Sciences, Kyushu University
Division name	Clinical Radiology
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	Koji Yamashita
Organization	Departments of Clinical Radiology, Graduate School of Medical Sciences, Kyushu University
Division name	Clinical Radiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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