UMIN-CTR Clinical Trial

Basic information
Public title	The utility of imaging findings using new sequence of MRI in brain tumor
Acronym	The utility of imaging findings using new sequence of MRI in brain tumor
Scientific Title	The utility of imaging findings using new sequence of MRI in brain tumor
Scientific Title:Acronym	The utility of imaging findings using new sequence of MRI in brain tumor
Region	Japan

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

Objectives
Narrative objectives1	To assess the utility of MR imaging findings using new sequence in brain tumor.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) To correlate signal intensity of APT imaging and histopathological findings in brain tumor. 2) To correlate signal intensity of APT imaging and imaging findings on other sequences after chemotherapy and/or radiation therapy. 3) To correlate signal intensity of eASL and histopathological findings in brain tumor. 4) To correlate signal intensity of eASL and imaging findings on other sequences after chemotherapy and/or radiation therapy.
Key secondary outcomes	1) To correlate signal intensity of eASL and conventional ASL. 2) To compare the image quality of eASL and signal intensity of dynamic susceptibility contrast in brain tumor.

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	1) Patients who agree and write informed consent form If subjects are child, their parent or guardian write informed consent form 2) patient who undergo MRI imaging for medical treatment 3) patients who have brain tumors or are suspected to have brain tumors 4) patient who received chemotherapy and radiation therapy after brain tumor surgery
Key exclusion criteria	1) patients who cannot lie down for 1 hour 2) pregnant patients 3) claustrophobia 4) patients who are considered not to be suitable for the research by research representative
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Shinya Middle name Last name Fujii
Organization	Tottori university
Division name	Department of radiology
Zip code	683-8504
Address	36-1, Nishi-cho, Yonago
TEL	0859-38-6637
Email	sfujii@tottori-u.ac.jp

Public contact
Name of contact person	1st name Shinya Middle name Last name Fujii
Organization	Tottori university
Division name	Department of radiology
Zip code	683-8504
Address	36-1, Nishi-cho, Yonago
TEL	0859-38-6637
Homepage URL
Email	sfujii@tottori-u.ac.jp

Sponsor
Institute	Tottori university
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	institutional reveiw board
Address	36-1, Nishi-cho, Yonago
Tel	0859-38-7108
Email	me-kenkyu@adm.tottori-u.ac.jp

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	2019 Year 04 Month 15 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	2019 Year 04 Month 10 Day
Date of IRB	2019 Year 03 Month 25 Day
Anticipated trial start date	2019 Year 04 Month 15 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2019 Year 04 Month 14 Day
Last modified on	2021 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041591