UMIN-CTR Clinical Trial

Basic information
Public title	7T MRI in sudden deafness
Acronym	7T MRI in sudden deafness
Scientific Title	7T MRI in sudden deafness
Scientific Title:Acronym	7T MRI in sudden deafness
Region	Japan

Condition
Condition	sudden deafness
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the pathophysiology of sudden deafness using 7T MRI
Basic objectives2	Others
Basic objectives -Others	To see the change of the endolymph and perilymph
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To see the change of signal intensity in the endolymphatic space and perilymphatic space
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Those fulfilling the criteria established by the Sudden Deafness Research Committee of the Ministry of Health and Welfare, Japan (2015)
Key exclusion criteria	1) Those with metal within the body 2) Those with claustrophobia 3) Those who can not stay still more than 45 minutes 4) Those who are or may be pregnant 5) Those who did not agree to participate in this study 6) Those who were judged to be inappropriate for this study In cases using gadolinium 7) Those who had experienced adverse reaction to the gadolinium 8) Those with bronchial asthma 9) Those with or may with epilepsy 10) Those with sever liver or kidney diseases
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Harukazu Middle name Last name Hiraumi
Organization	Iwate Medical University
Division name	Otolaryngology
Zip code	028-3695
Address	2-1-1, idai doori, Yahaba City, Shiwa, Iwate, Japan
TEL	0196137111
Email	hhiraumi@iwate-med.ac.jp

Public contact
Name of contact person	1st name Harukazu Middle name Last name Hiraumi
Organization	Iwate Medical University
Division name	Otolaryngology
Zip code	0283695
Address	2-1-1, idai doori, Yahaba City, Shiwa, Iwate, Japan
TEL	0196137111
Homepage URL
Email	hhiraumi@iwate-med.ac.jp

Sponsor
Institute	Iwate Medical University
Institute
Department

Funding Source
Organization	self funding
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	Iwate Medical University
Address	2-1-1, idai doori, Yahaba City, Shiwa, Iwate, Japan
Tel	0196137111
Email	kenkyu-rinri@j.iwate-med.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	岩手医科大学

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 08 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	2020 Year 05 Month 26 Day
Date of IRB	2020 Year 11 Month 24 Day
Anticipated trial start date	2020 Year 06 Month 30 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To analyze the image of the inner ear of patients with sudden deafness using 7T MRI (Discovery MR950, GE healthcare)

Management information
Registered date	2020 Year 06 Month 05 Day
Last modified on	2021 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046419

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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