Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02358837
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 236

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study	3 year and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study	3 year and 6 months	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

Trial Locations

Locations (1)

University Hospital of Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland