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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036631
Receipt No. R000041732
Scientific Title Creating a Neural Imaging Sequence and Comparison with Conventional Methods
Date of disclosure of the study information 2019/04/30
Last modified on 2019/06/13

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Basic information
Public title Creating a Neural Imaging Sequence and Comparison with Conventional Methods
Acronym Creating a Neural Imaging Sequence and Comparison with Conventional Methods
Scientific Title Creating a Neural Imaging Sequence and Comparison with Conventional Methods
Scientific Title:Acronym Creating a Neural Imaging Sequence and Comparison with Conventional Methods
Region
Japan

Condition
Condition trigeminal neuralgia
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Create a neural visualization sequence with a contrast between nerves and blood vessels. Comparative study with conventional methods.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The contrast between nerves and blood vessels
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Duration of intervention:The dean of the School of Medicine approval date December 31, 2019
Contents of the intervention:Imaging by MRI
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
50 years-old >=
Gender Male and Female
Key inclusion criteria Healthy subjects
Key exclusion criteria MRI contraindications: a person with a pacemaker and a magnetic metal in the body
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Sutou
Middle name
Last name Takayuki
Organization Gunma University Hospital
Division name Radiation Department
Zip code 371-8511
Address # 39-15, Showa-machi, Maebashi-shi, Gunma
TEL 027-220-7111
Email ts1031bm@gunma-u.ac.jp

Public contact
Name of contact person
1st name Shogo
Middle name
Last name Tan
Organization Gunma University Hospital
Division name Radiation Department
Zip code 371-8511
Address # 39-15, Showa-machi, Maebashi-shi, Gunma
TEL 027-220-7111
Homepage URL
Email tan@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

Funding Source
Organization Non
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 Medical Research Ethics Review Committee for People
Address # 39-15, Showa-machi, Maebashi-shi, Gunma
Tel 027-220-8740
Email hitotaisho-ciru@ml.gunma-u.ac.jp

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
2019 Year 04 Month 30 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 11
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
2018 Year 01 Month 29 Day
Date of IRB
2018 Year 01 Month 29 Day
Anticipated trial start date
2018 Year 01 Month 29 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 30 Day
Last modified on
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041732

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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