Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study

Improving Breast Cancer Diagnostics by Novel Sonographic Techniques

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02358837

Acronym

RadioUS

Enrollment

236

Registered

2015-02-09

Start date

2011-08-31

Completion date

2015-01-31

Last updated

2018-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

elastosonography, comparing conventional sonography with ductosonography

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study	3 year and 6 months	Comparing Time of Both Procedures of Conventional Sonography Versus Ductosonography Technique Elastosonography

Secondary

Measure	Time frame	Description
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

Countries

Switzerland

Outcome results