UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034889 |
|---|---|
| Receipt number | R000039768 |
| Scientific Title | Investigation of MRI protocols for trigeminal neuralgia patients. |
| Date of disclosure of the study information | 2018/11/14 |
| Last modified on | 2022/05/18 09:33:15 |
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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
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
hiro.orad@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
MR cistenography for tregeminal neuralgia.
Publication of results
Partially published
Result
URL related to results and publications
Nothing to register
Number of participants that the trial has enrolled
40
Results
The conventional examination for trigeminal neuralgia patients is CISS sequence, but a new sequence named as SPASS appeared that would present better image. We tried to evaluate whether the SPACE image would be better than the CISS.
Results date posted
| 2022 | Year | 05 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with trigeminal neuralgia
Participant flow
The patients receipt an additive SPACE examination to the routine CISS examination.
Adverse events
No report about adverse events.
Outcome measures
We evaluated the CISS and SPACE images about trigeminal neuralgia patients.
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
| 2022 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039768
