Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study

Breast Cancer Clinical Trial

— RadioUS  

Official title:

Improving Breast Cancer Diagnostics by Novel Sonographic Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358837
• Other study ID #: 204.08.2011
• Status: Completed
• Start date: August 2011
• Est. completion date: January 2015

Study information

• Verified date: May 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Switzerland	University Hospital of Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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