Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study

Study Overview
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Brief Summary
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With the proposed project we seek to advance the detection and diagnosis of breast cancer in an outpatient breast clinic. Novel sonographic approaches will be scrutinized. The first aim of this study will be to explore whether there is an advantage of ductosonography over conventional breast sonography in detecting and localizing breast lesions by comparing the diagnostic accuracy of ductosonography and conventional breast sonography in detecting suspicious and unclear sonographic lesions.In Addition, reliability and time requirement of ductosonographic examination will be investigated. The second specific aim is to investigate the potential of tissue elasticity as a diagnostic marker in solid breast lesions (US-BI-RADS 3, 4 and 5) by elastosonography. The study design allows investigating the reproducibility of the method.

Detailed Description
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The Research Project consists of mainly two parts that involve different methodological approaches: For the first part, different breast ultrasound techniques will be employed for the examination of an unselected population in a regular setting of a breast outpatient clinic. The second part includes measuring and characterizing tissue elasticity of breast lesions by elastosonography.

Official Title
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Improving Breast Cancer Diagnostics by Novel Sonographic Techniques

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:all women , who agree with the two examinations of the breast: conventional method and ductosonography Exclusion Criteria: a women, who have only the conventional examination of sonography

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conventional Sonography<br>Conventional Sonography to detect breast lesion | |
| Ductosonography Technique<br>Ductosonography Technique to detect breast lesion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study | Comparing Time of Both Procedures of Conventional Sonography Versus Ductosonography Technique Elastosonography | 3 year and 6 months | 
| Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study | Comparing the diagnostic accuracy of ductosonography and conventional breast sonography in the detection of breast lesions. Suspicious and unclear sonographic lesions (BI-RADS 3, 4, and 5) are clarified with a breast biopsy and malignancy confirmed by histology. | 3 year and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study | Spatial precision will be evaluated by measuring the deviation in millimeters of sonographic detection sites from the site of the biopsy. Comparing the time requirement for ductosonography and traditional sonography in minutes | 3 year and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elastosonography, comparing conventional sonography with ductosonography