UMIN-CTR Clinical Trial

Basic information
Public title	Monitoring inner ear hydrops by using Gd-MRI
Acronym	Gd-MR for hydrops patients
Scientific Title	Monitoring inner ear hydrops by using Gd-MRI
Scientific Title:Acronym	Gd-MR for hydrops patients
Region	Japan

Condition
Condition	inner ear disorders
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	There are two compartments separated by the epithelial structure in the inner ear: perilymph and endolymph. Endolymphatic hydrops is a state in which the proportion of the latter is increased, and it is known as a pathology of variable symptoms of inner ear disorder (hearing loss, dizziness, equilibrium disorder). Recently, a technique to visualize endolymph in the contrast MRI has been reported: IV injection of the contrast agent 4 hours before MRI imaging renders endolymph with nice spatial resolution. Diagnostic criteria in Japan for Meniere's disease, which is a clinical disease name of endolymphatic hydrops, also includes this imaging tests. The main purpose of this study is to analyze the changes on the contrast MRI before, during and after the time of treatments in endolymphatic hydrops patients. The secondary purpose is to optimize image analysis of the method at our 3T contrast MRI (GE).
Basic objectives2	Others
Basic objectives -Others	Regarding this research method, there is little report on the image analysis with MR scan of GE. Diagnostic power using the machine is also examined exploratively in this research.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of visualization of endolymphatic edema before, during and after treatments.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Among clinical endolymphatic hydrops patients who are visiting Keio University Hospital, have the capacity to agree and with whom treatments for hydrops will be given.
Key exclusion criteria	1) patients with kidney dysfunction 2) patients with a history of allergy by Gd contrast agent
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Sho Middle name Last name Kanzaki
Organization	Keio University Hospital
Division name	Otorhinolaryngology
Zip code	160-8582
Address	35, Shinanomachi Shinjuku Tokyo Japan
TEL	03-5363-3827
Email	skan@keio.jp

Public contact
Name of contact person	1st name Sho Middle name Last name Kanzaki
Organization	Keio University Hospital
Division name	Otorhinolaryngology
Zip code	160-8582
Address	35, Shinanomachi Shinjuku Tokyo Japan
TEL	03-5363-3827
Homepage URL
Email	otol.group@gmail.com

Sponsor
Institute	Keio University Hospital
Institute
Department

Funding Source
Organization	AMED, JSPS, MHLW, Donations
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research Ethics Committee
Address	35 Shinanomachi, Shinjuku, Tokyo
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.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	2018 Year 08 Month 16 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	2018 Year 05 Month 11 Day
Date of IRB	2018 Year 07 Month 02 Day
Anticipated trial start date	2018 Year 08 Month 15 Day
Last follow-up date	2022 Year 03 Month 30 Day
Date of closure to data entry	2022 Year 03 Month 30 Day
Date trial data considered complete	2022 Year 03 Month 30 Day
Date analysis concluded	2022 Year 03 Month 30 Day

Other
Other related information	Changes in the MR images will be evaluated

Management information
Registered date	2018 Year 08 Month 13 Day
Last modified on	2022 Year 04 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038463