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

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.

Study Overview

• Status: Unknown
• Conditions: Mammographic Breast Density
• Intervention / Treatment: Device: Volpara

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Recruiting
      • Radiology Breast Unit, Hospital Parc Taulí
      • Contact: Javier del Riego, MD; Phone Number: 26 001 +34 93 717 11 54; Email: jdelriego@tauli.cat
      • Principal Investigator: Oliver Diaz, PhD
      • Principal Investigator: Javier del Riego, MD
      • Sub-Investigator: Amaya Martín, MD
      • Sub-Investigator: Lidia Tortajada, MD
      • Sub-Investigator: M Teresa Villajos, MD
      • Sub-Investigator: Clara Codina, MD
      • Sub-Investigator: Fernanda Escribano, MD
      • Sub-Investigator: Laura Navarro
      • Sub-Investigator: Joan C Oliva
      • Sub-Investigator: M Magdalena Villa
      • Sub-Investigator: Rosa Ariza
      • Sub-Investigator: Cecilia Aynes
      • Sub-Investigator: Estefania Martín
      • Sub-Investigator: Eva Doncel
      • Sub-Investigator: Robert Martí, PhD
      • Sub-Investigator: Eloy García, PhD
      • Sub-Investigator: Anissa Lingtang, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Asymptomatic women with age greater than 40 who has signed a consent form.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Collaborators: University of Barcelona; Universitat de Girona

Publications and helpful links

Helpful Links

• Breast density software which will be evaluated

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: October 12, 2019
• First Submitted That Met QC Criteria: October 12, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Breast cancer; Digital Mammography; Digital Breast Tomosynthesis; Quantra; BI-RADS; Breast density; Volpara
• Other Study ID Numbers: 2019/629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes