Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

Study Overview
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Brief Summary
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The investigators hypothesis is that the combined use of elastography and color doppler ultrasonography can increase positive-predictive value of breast screening with ultrasound.

Detailed Description
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Asymptomatic women who undergo breast screening with ultrasound and has breast masses of Breast Imaging Reporting and Data System (BI-RADS) category 3 or higher will be examined with conventional B-mode US as well as combined elasto-doppler US by breast radiologists. The likelihood of malignancy and BI-RADS category of the breast masses are assessed for each dataset of B-mode US alone and B-mode US with elasto-doppler US, respectively. Reference standard: Biopsy or 1 year of follow-up examination. The positive-predictive value, sensitivity, specificity, and diagnostic accuracy (assessed by the area under the receiver operating characteristic curve) are evaluated and compared between B-mode US alone and B-mode US with elasto-doppler US.

Official Title
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Multicenter Prospective Study to Evaluate the Value of Combined Elastography and Color Doppler Ultrasonography for Breast Screening With Ultrasound

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Ultrasonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 30 years or older screened with breast ultrasound without specific symptoms Women who underwent mammography within 3 months which showed no abnormality except for dense breast Women who had at least one breast mass of BI-RADS category 3 or higher. Exclusion Criteria: Women with breast implants Women who are unwilling or unable to provide informed consent Lesions larger than 3 cm Lesions that are previously noted and followed-up in the same hospital

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast masses detected with screening US<br>Those assessed with conventional B-mode US alone and those assessed with combined elastography and color doppler ultrasonography along with B-mode US. | Device: Ultrasonography<br>* Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US.<br>* Other names: EUB-series/HV-ASCENDUS (Hitachi Medical, Japan);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value of breast screening with US | Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy. | 1 year after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy. | 1 year after enrollment | 
| Specificity | Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy. | 1 year after enrollment | 
| Diagnostic accuracy | Stability for 1 year of follow-up is needed for the confirmation of benign lesions if they do not undergo biopsy. | 1 year after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast, Screening, Ultrasound, Elastography, Doppler ultrasonography