UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004824 |
|---|---|
| Receipt number | R000005740 |
| Scientific Title | Development of clinical Magnetic Resonance Imaging techniques using high field magnetic resonance |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2016/07/15 16:00:51 |
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Basic information
Public title
Development of clinical Magnetic Resonance Imaging techniques using high field magnetic resonance
Acronym
Clinical MRI technique development
Scientific Title
Development of clinical Magnetic Resonance Imaging techniques using high field magnetic resonance
Scientific Title:Acronym
Clinical MRI technique development
Region
| Japan |
Condition
Condition
liver cirrhosis
gynecological diseases
myopia
donor of liver transplantation
Hypertension
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Cardiology |
| Pneumology | Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
| Ophthalmology | Radiology | Neurosurgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our first object is to adjust 3T MR machine located for only research that was developed at NEDO project, for clinical usage.
Secondly, providing highly advanced examination for the patients is important object by establishing the new MR taking sequences.
Basic objectives2
Others
Basic objectives -Others
Detection of image changes related to pathophysiology.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Investigation of diagnostic capability of a new acquisition method
Key secondary outcomes
Evalulation of image quality and artifacts of a new acquisition method
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
taking MR imaging
Interventions/Control_2
taking MR imaging
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients who agreed to takiing MR images
Key exclusion criteria
Contraindication of MRI scan
Poor image quality
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Togashi |
Organization
Kyoto university
Division name
diagnostic radiology and nuclear medicine
Zip code
Address
57ShogoinKawahara-cho, Sakyo, Kyoto city, Kyoto
TEL
075-751-3760
ktogashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aki KIDO |
Organization
Kyoto university
Division name
diagnostic radiology and nuclear medicine
Zip code
Address
57ShogoinKawahara-cho, Sakyo, Kyoto city, Kyoto
TEL
075-751-3760
Homepage URL
akikido@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university
Institute
Department
Personal name
Funding Source
Organization
Toshiba medical Systems Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Toshiba medical Systems Corporation
Name of secondary funder(s)
no
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 01 | 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
Comparison of non-contrast enhanced brain angiography between FSBB and TOF
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
| 2011 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 06 | Day |
Last modified on
| 2016 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005740
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
