UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037887 |
|---|---|
| Receipt number | R000043193 |
| Scientific Title | Investigation of diffusion tensor imaging for visualization of tongue muscle |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2025/03/07 12:36:36 |
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Basic information
Public title
Investigation of diffusion tensor imaging for visualization of tongue muscle
Acronym
Diffusion tensor imaging for visualization of tongue muscle
Scientific Title
Investigation of diffusion tensor imaging for visualization of tongue muscle
Scientific Title:Acronym
Diffusion tensor imaging for visualization of tongue muscle
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Oral surgery | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study is to perform quantitative evaluation and fibre tracking of the tongue muscles using DTI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The visualization quality of tongue muscles and quantitative measurement values are evaluated.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Three-dimensional T1 weighted images and Diffusion tensor images are obtained using a 3.0-T MRI scanner.
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
Healthy subjects
Key exclusion criteria
Subjects for whom MRI are contraindicated
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | |
| Last name | SAKAMOTO |
Organization
Tokyo Medical and Dental University, Graduate School
Division name
Oral and maxillofacial radiology
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo.
TEL
03-5803-5547
sakajun.orad@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Junichiro |
| Middle name | |
| Last name | SAKAMOTO |
Organization
Tokyo Medical and Dental University, Graduate School
Division name
Oral and maxillofacial radiology
Zip code
113-8549
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo.
TEL
03-5803-5547
Homepage URL
sakajun.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
1-5-45 Yushima, Bunkyo-ku, Tokyo.
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
| 2019 | Year | 09 | Month | 02 | 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
Five healthy volunteers were underwent MRI including the DTI and 3D T1-weighted imaging. To visualize the tongue muscle fiber three-dimensionally, fiber tacking was performed. In the quantitative evaluation, FA values of tongue muscles were measured by two observers. In all volunteers, the tongue muscle fibers could be visualized fully or partially by tractography.
Results date posted
| 2020 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | 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
| 2019 | Year | 09 | Month | 02 | Day |
Last modified on
| 2025 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043193
