Study of Breast Density Effects on Mammogram Accuracy and Breast Cancer Screening Outcomes Using Automated Assessment in Women Aged 45 to 75

What this Trial Is About

This observational study examines how breast density affects the accuracy and outcomes of mammographic screening for breast cancer within the regional Prevenzione Serena program at ASL CN2. It focuses on women aged 45 to 75 years who underwent routine screening between September 2023 and May 2024. The study evaluates the association between breast density categories BI-RADS A-D and the frequency of recalls for additional diagnostic tests, aiming to understand how dense breast tissue impacts detection and false-positive rates. The research includes an internal validation of Insight BD, an automated software used to measure breast density. This validation involves technical testing with a mammography phantom and comparisons of the softwares BI-RADS classifications with assessments from two radiologists. No treatments or interventions are given, as data are collected retrospectively from clinical records. The study also explores how factors like menopausal status, hormone therapy, and family history relate to breast density and screening outcomes. Participants data will be analyzed for recall rates for second-level exams such as ultrasound or MRI, false-positive findings, and breast density distribution. Researchers will monitor the softwares accuracy and agreement with radiologists readings. The primary outcome is the recall rate by breast density category during the screening period. The study aims to inform future personalized screening guidelines and improve breast cancer detection strategies for women with dense breasts.

Breast Density Impact on Mammographic Screening for Breast Cancer Diagnosis