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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017518
Receipt No. 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

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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
Email 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
Email yamakou@radiol.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020299

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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