UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diffusion weighted imaging with silent technique
Title of the study (Brief title)	Quiet DWI
Region	Japan

Condition
Condition	pediatric patients
Classification by specialty	Pediatrics Neurosurgery Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Benefit of quiet DWI
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Image quality of DWI
Key secondary outcomes

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	0 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Pediatric patients who underwent brain MR.
Key exclusion criteria	Poor image quality
Target sample size	480

Research contact person
Name of lead principal investigator	Kaori Togashi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Diagnostic Imaging and Nuclear Medicine
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL	+81-75-751-3760
Email	nmdioffice@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Yasutaka Fushimi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Diagnostic Imaging and Nuclear Medicine
Address	54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL	+81-75-751-3760
Homepage URL
Email	nmdioffice@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Fundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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	2017 Year 09 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Image quality of DWI will be compared between DWI with/without silent technique.

Management information
Registered date	2017 Year 08 Month 28 Day
Last modified on	2017 Year 08 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033035