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Completed

NCT Number: NCT02358837

Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital of Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study

    Time frame: 3 year and 6 months

    Comparing Time of Both Procedures of Conventional Sonography Versus Ductosonography Technique Elastosonography

  2. 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

  1. Improving Breast Cancer Diagnostic by Novel sonographicTechniques Study

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Improving Breast Cancer Diagnostics by Novel Sonographic Techniques

Acronym: RadioUS

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 9, 2015
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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