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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-08-31

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.

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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.

Conditions

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Mammographic Breast Density

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes