UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010692 |
|---|---|
| Receipt number | R000012441 |
| Scientific Title | the establishment of noninvasive method for evaluation of breast lesions using perfusion and diffusion weighted MR imaging |
| Date of disclosure of the study information | 2013/05/13 |
| Last modified on | 2020/11/14 09:39:23 |
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Basic information
Public title
the establishment of noninvasive method for evaluation of breast lesions using perfusion and diffusion weighted MR imaging
Acronym
the establishment of noninvasive method for evaluation of breast lesions using perfusion and diffusion weighted MR imaging
Scientific Title
the establishment of noninvasive method for evaluation of breast lesions using perfusion and diffusion weighted MR imaging
Scientific Title:Acronym
the establishment of noninvasive method for evaluation of breast lesions using perfusion and diffusion weighted MR imaging
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a new diagnostic method of cancer to explore the potential of the diffusion and perfusion MRI parameters obtained from IVIM MRI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic performance
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 meet all of the following conditions.
1. Breast cancer is suspected clinically.
2. A MRI scan was ordered for staging.
3. Written informed consent was obtained.
Key exclusion criteria
Patients who meet at least one of the following conditions.
1. Communication difficulty.
2. General conditions are extremely poor.
3. Informed consent not given.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Togashi |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Radiology
Zip code
6068507
Address
54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
TEL
075-751-3760
mamiiima@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Iima |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Radiology
Zip code
6068507
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
Kyoto University Graduate School of Medicine, Ethics Comittee
Address
54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto
Tel
075-753-9470
ethcom@kuhp.kyoto-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
| 2013 | Year | 05 | Month | 13 | 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
| 2013 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study acquiring the new data
Management information
Registered date
| 2013 | Year | 05 | Month | 10 | Day |
Last modified on
| 2020 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012441
