UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018792 |
|---|---|
| Receipt number | R000019793 |
| Scientific Title | Correlation of the proton density fat fraction in the parotid gland and the submandibular gland obtained by Dixon method and that by MR spectroscopy. |
| Date of disclosure of the study information | 2015/08/25 |
| Last modified on | 2018/02/26 15:08:21 |
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Basic information
Public title
Correlation of the proton density fat fraction in the parotid gland and the submandibular gland obtained by Dixon method and that by MR spectroscopy.
Acronym
The estimation of fat fraction of the salivary gland by MRI
Scientific Title
Correlation of the proton density fat fraction in the parotid gland and the submandibular gland obtained by Dixon method and that by MR spectroscopy.
Scientific Title:Acronym
The estimation of fat fraction of the salivary gland by MRI
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Radiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the fat faction obtained by Dixon method and that by MRS method, which is a gold standard.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The correlation of fat fraction obtained by Dixon method and that by MRS.
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
The healthy volunteers included in this study undergo the MRI and MRS in the parotid glands and submandibular glands. We estimate the fat fraction of the salivary glands using both Dixon method and MR spectroscopy. The registration deadline is 31st, March 2016.
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 volunteers without contraindication to MR scan.
Key exclusion criteria
Healthy volunteers with contraindication to MR scan.
The volunteers who cannot keep the spine position for thirty minutes.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Yoshiura |
Organization
Kyushu University, Faculty of dental science.
Division name
Department of Oral and Maxillofacial radiology
Zip code
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka
TEL
0926426407
yoshiura@rad.dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Chikui |
Organization
Kyushu University, Faculty of dental science.
Division name
Department of Oral and Maxillofacial radiology
Zip code
Address
3-1-1, Maidashi, Higashi-Ku, Fukuoka
TEL
0926426407
Homepage URL
chikui@rad.dent.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University, Faculty of dental science.
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 08 | Month | 25 | 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
| 2014 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 25 | Day |
Last modified on
| 2018 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019793
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| Registered date | File name |
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| Registered date | File name |
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