UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025564 |
|---|---|
| Receipt number | R000029422 |
| Scientific Title | Assessment of clinical utility of non-enhanced 4-dimentional MR angiography |
| Date of disclosure of the study information | 2017/01/18 |
| Last modified on | 2018/06/09 14:15:15 |
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Basic information
Public title
Assessment of clinical utility of non-enhanced 4-dimentional MR angiography
Acronym
Assessment of clinical utility of non-enhanced 4-dimentional MR angiography
Scientific Title
Assessment of clinical utility of non-enhanced 4-dimentional MR angiography
Scientific Title:Acronym
Assessment of clinical utility of non-enhanced 4-dimentional MR angiography
Region
| Japan |
Condition
Condition
cerebrovascular disease
Classification by specialty
| Neurology | Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical utility of non- enhanced 4D MRA with cerebro- vascular disease
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluation of image quality of non-enhanced 4D MRA
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
| Device,equipment |
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who receive medical treatment due to cerebrovascular disease in department of neurosurgery or neurology of Tokyo Women's Medical University
Key exclusion criteria
1. Patients who have metal or an electronic device, such as a pacemaker, implanted.
2. Patients who are claustrophobic
3. Patients judged inappropriate by the research doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuji Sakai |
Organization
Tokyo Women's Medical University
Division name
Dept. of Diagnostic Imaging and Nuclear Medicine
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
sakai.shuji@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kayoko Abe |
Organization
Tokyo Women's Medical University
Division name
Dept. of Diagnostic Imaging and Nuclear Medicine
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
abe.kayoko@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
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
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 18 | 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
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
| 2015 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2017 | Year | 01 | Month | 06 | Day |
Last modified on
| 2018 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029422
