UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017518 |
|---|---|
| Receipt number | R000020299 |
| Scientific Title | High-resolution diffusion-weighted Imaging of acquired cholesteatoma |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2017/09/05 11:02:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
High-resolution diffusion-weighted Imaging of acquired cholesteatoma
Acronym
High-resolution DWI of acquired cholesteatoma
Scientific Title
High-resolution diffusion-weighted Imaging of acquired cholesteatoma
Scientific Title:Acronym
High-resolution DWI of acquired cholesteatoma
Region
| Japan |
Condition
Condition
Cholesteatoma
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our purpose was to evaluate the utility of high resolution DWI for the diagnosis of middle-ear cholesteatoma by comparing it to conventional DWI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the detection of cholesteatoma between high resolution DWI and conventional 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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with preoperatively suspected acquired cholesteatoma
Participants with obtaining written informed consent
Key exclusion criteria
Patients with implanted cardiac pacemaker, cochlear implants, claustrophobia
In pregnancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Honda |
Organization
Kyushu University
Division name
Department of Clinical Radiology
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582 JAPAN
TEL
092-642-5705
honda@radiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Yamashita |
Organization
Kyushu University
Division name
Departments of Clinical Radiology
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582 JAPAN
TEL
092-642-5705
Homepage URL
yamakou@radiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Address
Tel
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
| 2015 | Year | 05 | Month | 12 | 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
| 2014 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
DWI of 30 patients will be reviewed by two independent neuroradiologists who were blinded to the patients' clinical information.
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2017 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020299
