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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033730
Receipt No. R000038463
Scientific Title Monitoring inner ear hydrops by using Gd-MRI
Date of disclosure of the study information 2018/08/16
Last modified on 2019/08/14

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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 Enrolling by invitation
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
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2019 Year 08 Month 14 Day


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

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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