UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033730 |
|---|---|
| Receipt number | R000038463 |
| Scientific Title | Monitoring inner ear hydrops by using Gd-MRI |
| Date of disclosure of the study information | 2018/08/16 |
| Last modified on | 2022/04/19 09:41:43 |
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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
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
otol.group@gmail.com
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038463
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
