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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009681
Receipt No. 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

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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
Email 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
Email a_nagai@sitama-med.ac.jp

Sponsor
Institute Saitama Medical Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011354

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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