UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012595 |
|---|---|
| Receipt number | R000014299 |
| Scientific Title | the evaluation of the ultimate imaging method for breast lesions using perfusion and diffusion weighted MR |
| Date of disclosure of the study information | 2013/12/16 |
| Last modified on | 2015/06/16 16:27:27 |
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Basic information
Public title
the evaluation of the ultimate imaging method for breast lesions using perfusion and diffusion weighted MR
Acronym
the evaluation of the ultimate imaging method for breast lesions using perfusion and diffusion weighted MR
Scientific Title
the evaluation of the ultimate imaging method for breast lesions using perfusion and diffusion weighted MR
Scientific Title:Acronym
the evaluation of the ultimate imaging method for breast lesions using perfusion and diffusion weighted MR
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the ultimate acquisition method to explore the potential of the diffusion and perfusion MRI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the signal obtained from the sequence,and the deviation between the measured value and the estimated value calculated from the perfusion and diffusion parameters
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Protocol A
Interventions/Control_2
Protocol B
Interventions/Control_3
Protocol C
Interventions/Control_4
Protocol D
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
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
healthy volunteer who agrees to participate to the study with the age 20-60.
Key exclusion criteria
those who are not eligible for being scaned with MRI
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Togashi |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL
075-751-3760
nmdioffice@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mami Iima |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL
075-751-3760
Homepage URL
mamiiima@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | 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
Management information
Registered date
| 2013 | Year | 12 | Month | 16 | Day |
Last modified on
| 2015 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014299
