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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034889
Receipt No. R000039768
Scientific Title Investigation of MRI protocols for trigeminal neuralgia patients.
Date of disclosure of the study information 2018/11/14
Last modified on 2019/05/16

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Basic information
Public title Investigation of MRI protocols for trigeminal neuralgia patients.
Acronym MRI protocols for trigeminal neuralgia
Scientific Title Investigation of MRI protocols for trigeminal neuralgia patients.
Scientific Title:Acronym MRI protocols for trigeminal neuralgia
Region
Japan

Condition
Condition The aim of this study is the investigation of MRI protocols for trigeminal neuralgia patients.
Classification by specialty
Radiology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will investigate whether SPACE (sampling perfection with application-optimized contracts using different flip-angle evolutions) image is superior to CISS (constructive interference in steady state) image of MRI for trigeminal neuralgia patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate whether the diagnostic accuracy in SPACE image is superior to that in CISS image for trigeminal neuralgia patients.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 We will add a SPACE sequence examination for routine MRI examination for trigeminal neuralgia patients.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients with trigeminal neuralgia are planned for MRI examination.
Key exclusion criteria One is prohibited for MRI examination.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Watanabe
Organization Tokyo Medical and Dental University, Graduate School of Dentistry.
Division name Oral and Maxillofacial Radiology
Zip code 113-8549
Address Yushima 1-5-45, Bunkyo-ku, Tokyo-to
TEL +81-3-5803-5545
Email hiro.orad@tmd.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Watanabe
Organization Tokyo Medical and Dental University, Graduate School of Dentistry.
Division name Oral and Maxillofacial Radiology
Zip code 113-8549
Address Yushima 1-5-45, Bunkyo-ku, Tokyo-to
TEL +81-3-5803-5545
Homepage URL
Email hiro.orad@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address Yushima 1-5-45, Bunkyo-ku, Tokyo-to
Tel 03-5803-5404
Email d.somu.adm@cmn.tmd.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 11 Month 14 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 04 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

Management information
Registered date
2018 Year 11 Month 14 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039768

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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