UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053206 |
|---|---|
| Receipt number | R000060715 |
| Scientific Title | Attempt to visualize and quantify saliva by Dynamic MR Sialography using ASL method. |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2023/12/23 11:55:18 |
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Basic information
Public title
Attempt to visualize and quantify saliva by Dynamic MR Sialography using ASL method.
Acronym
Attempt to visualize and quantify saliva by Dynamic MR Sialography using ASL method.
Scientific Title
Attempt to visualize and quantify saliva by Dynamic MR Sialography using ASL method.
Scientific Title:Acronym
Attempt to visualize and quantify saliva by Dynamic MR Sialography using ASL method.
Region
| Japan |
Condition
Condition
Sjogren's syndrome,Salivary gland dysfunction
Classification by specialty
| Endocrinology and Metabolism | Clinical immunology | Oto-rhino-laryngology |
| Radiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Applying ASL method of MRI to non-contrast saliva drainage and functional evaluation.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visually evaluate images depicting saliva flow
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
MRI is used to image the flow of saliva without contrast. The number of inspections was once. Test time is 30 minutes. During the test, citric acid is injected into the oral cavity using an injector.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Volunteers, patients with decreased saliva secretion, and patients suspected of having Sjogren's syndrome.Patients receiving radiation therapy for head and neck malignant tumors.
Key exclusion criteria
none
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Kyogoku |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Radiology
Zip code
2790021
Address
Tomioka2-1-1, Urayasu-city, Chiba
TEL
0473533111
skyogoku@juntendo-urayasu.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Kyogoku |
Organization
Juntendo university Urayasu Hospital
Division name
Department of Radiology
Zip code
2790021
Address
Tomioka2-1-1, Urayasu-city, Chiba
TEL
0473533111
Homepage URL
skyogoku@juntendo-urayasu.jp
Sponsor or person
Institute
Juntendo university Urayasu Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Research Ethics Committee, Faculty of Medicine Juntendo University
Address
Hongo3-1-3, Bunkyou-ku, Tokyo
Tel
03-3814-5672
jcrtc_operation@juntendo.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
| 2023 | Year | 12 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 12 | Month | 23 | Day |
Last modified on
| 2023 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060715
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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