UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017511 |
|---|---|
| Receipt number | R000019521 |
| Scientific Title | Demonstration of salivary flow from the parotid gland by MRI using the time-spatial labeling inversion pulse (Time-SLIP) technique: Feasibility study in normal volunteers |
| Date of disclosure of the study information | 2015/05/15 |
| Last modified on | 2017/11/13 21:04:33 |
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Basic information
Public title
Demonstration of salivary flow from the parotid gland by MRI using the time-spatial labeling inversion pulse (Time-SLIP) technique: Feasibility study in normal volunteers
Acronym
Demonstration of salivary flow using Time-SLIP
Scientific Title
Demonstration of salivary flow from the parotid gland by MRI using the time-spatial labeling inversion pulse (Time-SLIP) technique: Feasibility study in normal volunteers
Scientific Title:Acronym
Demonstration of salivary flow using Time-SLIP
Region
| Japan |
Condition
Condition
normal volunteers
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assessed the feasibility of the Time-SLIP technique for demonstrating the salivary flow in normal volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We scored visualization of the parotid duct on the flow images.
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
| Other |
Interventions/Control_1
We scanned the parotid duct 23 times at identical intervals. To stimulate salivary secretion we injected 1 mL of 2% citric acid into the mouth before scans 4, 8, 12, 16, and 20.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
normal volunteers without salivary disease
Key exclusion criteria
contraindication for MRI (claustrophobia and metal in the body)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Awai |
Organization
Hiroshima University
Division name
Department of Diagnostic Radiology
Zip code
Address
1-2-3 Kasum Minamiku Hiroshima Japan
TEL
082-257-5257
awai@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Wataru Fukumoto |
Organization
Hiroshima University
Division name
Department of Diagnostic Radiology
Zip code
Address
1-2-3 Kasum Minamiku Hiroshima Japan
TEL
082-257-5257
Homepage URL
wfukumoto@hiroshima-u.ac.jp
Sponsor or person
Institute
Kazuo Awai
Institute
Department
Personal name
Funding Source
Organization
Department of Diagnostic Radiology
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
Address
Tel
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
| 2015 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2017 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019521
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| Registered date | File name |
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