UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009681 |
|---|---|
| Receipt number | R000011354 |
| Scientific Title | Study on imaging parameters in CSF flow rate measurement method using Phase-Contrast. |
| Date of disclosure of the study information | 2013/01/07 |
| Last modified on | 2014/01/03 10:34:14 |
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Basic information
Public title
Study on imaging parameters in CSF flow rate measurement method using Phase-Contrast.
Acronym
Study on imaging parameters in CSF flow rate measurement method using Phase-Contrast.
Scientific Title
Study on imaging parameters in CSF flow rate measurement method using Phase-Contrast.
Scientific Title:Acronym
Study on imaging parameters in CSF flow rate measurement method using Phase-Contrast.
Region
| Japan |
Condition
Condition
Cervical myelopathy
Arnold-Chiari malformation
Classification by specialty
| Neurosurgery | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Brain essence liquid Phase Contrast flow velocity measurement method (CSF) is useful in the evaluation of before and after observation of the symptoms and surgery by quantitative evaluation. Therefore, in order to measure the CSF flow rate with high accuracy and stable, we examined the VENC is set imaging parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Velocity encoding(VENC) setting reasonable at the time of imaging.
Key secondary outcomes
Relation between a measurement (analysis) part and the flow velocity
Relation between age and the flow velocity.
Relation between a collection section. and the flow velocity.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Done by changing the encoding settings for shooting speed for proper quantitative measurement.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy adult cooperator.
2.Written informed consent.
Key exclusion criteria
1.Those who have symptoms such as pain and numbness.
2.Those who have the possibility of -pregnancy during pregnancy.
3.Those who have claustrophobia.
4.Those who are judged that have merged the mental disease or the neurological manifestation and the participation in an examination is difficult.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nagai |
Organization
Saitama Medical Center
Division name
Department of Radiology, Central
Zip code
Address
1981 Kamoda Kawagoe City, Saitama Prefecture
TEL
0492-28-3400
a_nagai@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Nagai |
Organization
Saitama Medical Center
Division name
Department of Radiology, Central
Zip code
Address
1981 Kamoda Kawagoe City, Saitama Prefecture
TEL
0492-28-3400
Homepage URL
a_nagai@sitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
埼玉医科大学総合医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 07 | 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
That from the measurement data of a healthy person, it is a constant velocity encoding because there is a difference in the individual is difficult. However, high correlation of CSF flow rate was observed in the sagittal and horizontal cross-section is the same between the wise man. Therefore, it was decided that velocity encoding checked whether the flow velocity in the sagittal, and performs each set in the horizontal cross-sectional. I suspect about 6 to 15 is suitable to velocity encoding of CSF measurement.
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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
I announced at the Japan Society of Radiological Technology 59th Kanto Division national conference.
Management information
Registered date
| 2013 | Year | 01 | Month | 03 | Day |
Last modified on
| 2014 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011354
