Breast Density Measurements in Digital Mammography and Breast Tomosynthesis Systems of Different Pixel Size

Study Overview
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Brief Summary
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Breast cancer (BC) is the most frequently diagnosed cancer in women worldwide. The cause of developing BC is currently unknown. However, there are several risk factors, such as volumetric breast density (VBD), which have been proved to have a relationship with BC. The assessment of breast density is typically performed subjectively using the 4-classes density classification described by American College of Radiology. However, in the last years, automated breast density software tools have been developed (e.g. Volpara, Quantra). In this work, VBD measurements from VolparaTM (v. 1.5.4.0) will be compared between Full-Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) of the same pacient ('combo mode'). Images will be acquired in a Hologic Selenia Dimensions, the most common FFDM/DTB system, where image resolution is different for FFDM (70 um) and DBT (140 um). This study (1) evaluates the consistency between Volpara's breast density measurements and spatial distribution for the two imaging techniques (FFDM and DBT) in a Hologic Selenia Dimensions, and (2) compares VDB measurements with other similar tool (Quantra) and radiologists breast density manual classification.

Detailed Description
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Monocentric, prospective and observational study which will analyse a series of 300 cases (FFDM + DBT) from consecutive women. Image acquisitions will take place within the Área de radiología Mamaria y Ginecológica located at Parc Taulí Hospital Universitari, Sabadell. The purposes of this study will be explained to each potential candidate and if agreed to participate, a consent form will be signed. Inclusion criteria: Subjects over 18 years old. Acceptance of participation through a signed consent form. Asymptomatic subjects Exclusion criteria: Subjects refusing to participate or sign the consent form. Subjects with prior history of breast surgery or biopsy with markers. Subjects with breast prostheses.

Official Title
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Breast Density Measurements in Digital Mammography and Breast Tomosynthesis Systems of Different Pixel Size

Conditions
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Mammographic Breast Density

Intervention / Treatment
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* Device: Volpara


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acceptance of participation through a signed consent form. Asymptomatic subjects Exclusion Criteria: Subjects refusing to participate or sign the consent form. Subjects with prior history of breast surgery or biopsy with markers. Subjects with breast prostheses. Subjects with biopsy marker clips

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Volpara|This tool represents a physics-based model which extract pixel-wise information from the FFDM or DBT images, and combine it with metadata information from the DICOM header and appropriate linear attenuation coefficients of both adipose and glandular tissue.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency of breast density measurements from the latest VolparaTM breast density tool for Hologic's FFDM and DBT images (i.e. combo mode). |  | 1 year | 
| Comparison of VolparaTM's Volumetric Breast Density measurements and its 4-classes density rating measured in DBT against QuantraTM 3D and radiologist's BI-RADS manual classification |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Breast density, Volpara, Quantra, BI-RADS, Digital Mammography, Digital Breast Tomosynthesis