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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017511
Receipt No. 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

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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
Email 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
Email wfukumoto@hiroshima-u.ac.jp

Sponsor
Institute Kazuo Awai
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019521

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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