UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036631 |
|---|---|
| Receipt number | 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 10:35:25 |
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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
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
tan@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041732
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
