Clinical trial NCT02358837: Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
Official title: Improving Breast Cancer Diagnostics by Novel Sonographic Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: elastosonography
comparing conventional sonography with ductosonography
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The recruitment of ductosonography will target all women attending the outpatient breast clinic of the department og gynecology and Obstretic, University of 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.

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

Primary outcomes:
measure: Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
timeFrame: 3 year and 6 months
measure: Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
timeFrame: 3 year and 6 months
Secondary outcomes:
measure: Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study
timeFrame: 3 year and 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital of Basel
state: Basel-Stadt
Study officials:
affiliation: Claraspital Basel
name: Rosanna Zanetti, PD Dr Med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brasier-Lutz P, Jaggi-Wickes C, Schaedelin S, Burian R, Schoenenberger CA, Zanetti-Dallenbach R. Agreement in breast lesion assessment and final BI-RADS classification between radial and meander-like breast ultrasound. BMC Med Imaging. 2021 Jun 22;21(1):104. doi: 10.1186/s12880-021-00632-1.
citation: Jaggi-Wickes C, Brasier-Lutz P, Schaedelin S, Burian R, Schoenenberger CA, Zanetti-Dallenbach R. Comparison of radial and meander-like breast ultrasound with respect to diagnostic accuracy and examination time. Arch Gynecol Obstet. 2020 Jun;301(6):1533-1541. doi: 10.1007/s00404-020-05554-x. Epub 2020 May 3.