UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060736 |
|---|---|
| Receipt number | R000069485 |
| Scientific Title | Development of MR Cine Sialography for the Evaluation of Salivary Gland Function |
| Date of disclosure of the study information | 2026/02/23 |
| Last modified on | 2026/02/23 19:06:48 |
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Basic information
Public title
Development of MR Cine Sialography for the Evaluation of Salivary Gland Function
Acronym
Development of MR Cine Sialography for the Evaluation of Salivary Gland Function
Scientific Title
Development of MR Cine Sialography for the Evaluation of Salivary Gland Function
Scientific Title:Acronym
Development of MR Cine Sialography for the Evaluation of Salivary Gland Function
Region
| Japan |
Condition
Condition
Sjogren's syndrome,Salivary gland dysfunction, Volunteers
Classification by specialty
| Endocrinology and Metabolism | Geriatrics | Radiology |
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to perform MR cine sialography (MRCS) using the Time-Spatial Labeling Inversion Pulse (Time-SLIP) technique to simultaneously visualize the bilateral salivary glands and depict salivary flow from both the submandibular and parotid glands, and to evaluate salivary gland function and its clinical utility.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary flow visualized by MR cine sialography (MRCS) will be scored, and the following evaluations will be performed:
1. Correlation analysis between MRCS scores and salivary volume measured by the spitting method and gum-chewing test in healthy volunteers.
2. Comparison of MRCS scores between normal subjects and patients with Sjogren's syndrome (SS).
3. Association analysis between MRCS scores and diagnostic parameters included in the Japanese clinical guidelines, including labial salivary gland biopsy findings, oral examination results, ophthalmologic test results, serologic markers, and unstimulated salivary volume.
4. Comparative evaluation of MRCS with conventional MR sialography and structural MRI.
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 will be used to noninvasively visualize salivary flow without contrast agents. The examination will be performed once, with a total scan time of approximately 30 minutes. During the examination, citric acid will be administered 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
Healthy volunteers; patients with reduced salivary secretion; patients with Sjogren's syndrome; and patients with head and neck malignancies before and after radiotherapy.
Key exclusion criteria
Individuals with MRI-incompatible metallic implants; individuals with severe claustrophobia; and individuals who request discontinuation of the examination.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Koizumi |
Organization
Juntendo University Hospital
Division name
Department of Radiology
Zip code
113-8431
Address
Hongo3-1-3, Bunkyou-ku, Tokyo
TEL
03-3813-3111
t.koizumi.zb@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Koizumi |
Organization
Juntendo University Hospital
Division name
Department of Radiology
Zip code
113-8431
Address
Hongo3-1-3, Bunkyou-ku, Tokyo
TEL
03-3813-3111
Homepage URL
t.koizumi.zb@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
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
| 2026 | Year | 02 | Month | 23 | 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
| 2025 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 02 | Month | 23 | Day |
Last modified on
| 2026 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069485
