UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024104 |
|---|---|
| Receipt number | R000027749 |
| Scientific Title | The utility of color Doppler shear wave imaging (CDSWI) for evaluating breast malignant tumors |
| Date of disclosure of the study information | 2016/09/30 |
| Last modified on | 2021/03/25 09:02:22 |
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Basic information
Public title
The utility of color Doppler shear wave imaging (CDSWI) for evaluating breast malignant tumors
Acronym
The utility of color Doppler shear wave imaging (CDSWI) for evaluating breast malignant tumors
Scientific Title
The utility of color Doppler shear wave imaging (CDSWI) for evaluating breast malignant tumors
Scientific Title:Acronym
The utility of color Doppler shear wave imaging (CDSWI) for evaluating breast malignant tumors
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the feasibility of the color Doppler sonography imaging as a novel clinical elastography for breast malignant tumors.
Basic objectives2
Others
Basic objectives -Others
To assess the qualitative and quantitative analyses of elastographic images.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The quantitative analysis of the elasticity of breast tumor
Key secondary outcomes
Reliability of data acquisition
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
Additional examination of sonography for breast cancer using a vibrator.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with diagnosis of breast cancer
Patients with agreement of this study based on proper informed consents
Key exclusion criteria
Patients after total mastectomy on both sides
Patients who would not be suitable for objects of this study by physicians
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Nakajima |
Organization
Gunma university
Division name
Molecular Imaging Division
Zip code
371-8511
Address
3-39-22, Showa, Maebashi, Gunma, Japan
TEL
027-220-8401
sojin@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Nakajima |
Organization
Gunma University Hospital
Division name
3-39-22, Showa, Maebashi, Gunma, Japan
Zip code
371-8511
Address
+81 27-220-8401
TEL
027-220-8401
Homepage URL
sojin@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Gunma University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Institutiional Review Board
Address
3-39-15, Showa, Maebashi, Gunma, JAPAN
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
群馬大学医学部附属病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
13
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
under reviewing
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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | 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
| 2016 | Year | 09 | Month | 20 | Day |
Last modified on
| 2021 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027749
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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