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Clinical Trials/NCT02358837
NCT02358837
Completed
Not Applicable

Improving Breast Cancer Diagnostics by Novel Sonographic Techniques

University Hospital, Basel, Switzerland1 site in 1 country236 target enrollmentAugust 2011
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University Hospital, Basel, Switzerland
Enrollment
236
Locations
1
Primary Endpoint
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
January 2015
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study

Time Frame: 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 Outcomes

  • Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study(3 year and 6 months)

Study Sites (1)

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