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

NCT04127175 | Unknown FDA Device

• 1 other identifier: 2019/629
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mammographic Breast Density

Keywords

Breast cancer; Breast density; Volpara; Quantra; BI-RADS; Digital Mammography; Digital Breast Tomosynthesis

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Volpara DEVICE

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.

Eligibility Criteria

• Age: 40 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Acceptance of participation through a signed consent form.
• Asymptomatic subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead
• University of Barcelona: collaborator
• Universitat de Girona: collaborator

Study Sites (1)

Radiology Breast Unit, Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Links

• Breast density software which will be evaluated

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Oliver Diaz, PhD

CONTACT

+34 93 402 08 55; oliver.diaz@ub.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting researcher

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: October 15, 2019
• Study Start: October 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: August 1, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

ES (1)