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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024104
Receipt No. 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 2017/05/17

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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
Middle name
Last name Takahito Nakajima
Organization Gunma university
Division name Molecular Imaging Division
Zip code
Address 3-39-22, Showa, Maebashi, Gunma, Japan
TEL 027-220-8401
Email sojin@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahito Nakajima
Organization Gunma University Hospital
Division name 3-39-22, Showa, Maebashi, Gunma, Japan
Zip code
Address +81 27-220-8401
TEL 027-220-8401
Homepage URL
Email sojin@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

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
Address
Tel
Email

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 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
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 08 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
2016 Year 09 Month 20 Day
Last modified on
2017 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027749

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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