About this trial
This retrospective, observational study aims to evaluate how breast density affects the accuracy and outcomes of mammographic screening for breast cancer within the regional screening program "Prevenzione Serena".
Breast density is an important factor because dense breast tissue can make it more difficult to detect breast cancer on a mammogram. Dense tissue and tumors both appear white on a mammogram, which may hide abnormalities and lead to missed cancers or false-positive results.
Women aged 45 to 75 years who underwent routine mammographic screening at ASL CN2 between September 2023 and May 2024 will be included. Breast density will be classified using the BI-RADS system (categories A-D), and the study will assess whether women with dense breasts (categories C and D) experience higher rates of recalls for second-level examinations such as ultrasound, MRI, etc).
The study also includes an internal validation of Insight BD, an automated breast-density measurement software used at ASL CN2. The software will be evaluated using a mammography phantom (to verify technical accuracy) and by comparing its BI-RADS density classifications with readings from two radiologists (one expert and one less experienced). This will help determine whether the software can support radiologists, especially in evaluating dense breast tissue.
Additional factors such as menopausal status, family history of breast cancer, and hormone therapy will also be examined to understand how they relate to breast density and screening outcomes. The study aims to quantify the frequency of false-positive recalls-cases in which additional tests are recommended but cancer is not found-because these events can increase patient anxiety and healthcare workload.
Ultimately, this research seeks to provide evidence that may inform future screening guidelines and support more personalized approaches, particularly for women with dense breasts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 45 to 75 years who participated in the "Prevenzione Serena" mammography screening program and underwent screening mammography at ASL CN2 between September 25, 2023, and May 3, 2024.
Signed informed consent or equivalent substitute declaration, when applicable.
Disqualifiers
Women with a history of mastectomy.
Women with breast implants.
Women with cardiac implantable devices, such as pacemakers or loop recorders.
Cases in which the Insight BD software cannot be applied due to compression thickness below 15 mm.
Trial population
The study will include women aged 45 to 75 years who participated in the "Prevenzione Serena" mammography screening program and underwent screening mammography at ASL CN2 using a Siemens MAMMOMAT Revelation mammography system between September 25, 2023, and May 3, 2024.
Trial design
Cohort
Retrospective
Treatments tested in this trial
No intervention is administered.
Other interventionNo intervention is administered.
Treatment groups
Trial outcomes
Primary outcomes
Recall Rate for Second-Level Examinations by BI-RADS Breast Density Category
Percentage of women recalled for second-level diagnostic examinations among all women undergoing mammographic screening, calculated separately for each BI-RADS density category (A, B, C, D) and for the dichotomized groups A-B versus C-D.
Secondary outcomes
Technical Performance of Insight BD: Accuracy and Repeatability on Breast Density Phantom
Evaluation of the volumetric breast density percentage produced by Insight BD on a standardized phantom, assessing measurement accuracy compared with the reference phantom values and repeatability across repeated acquisitions.
Concordance Between Insight BD BI-RADS Classification and Radiologist Assessment
Diagnostic agreement between Insight BD BI-RADS breast density classification and radiologist assessments. The outcome includes: * Percent agreement with the expert radiologist (primary reference). * Percent agreement with a non-expert radiologist to evaluate the tool's impact on less-experienced readers.
Recall Rate for Second-Level Examinations in Negative Mammographic Screens by BI-RADS Density
Proportion of women recalled for second-level diagnostic examinations among those with a negative screening mammogram, stratified by BI-RADS breast density categories (A, B, C, D) and by dichotomized density groups (A-B vs C-D).
Distribution of Breast Density by Menopausal Status, Hormonal Therapy, and Family History
Proportion of participants in each BI-RADS breast density category (A, B, C, D), and in dichotomized density groups (A-B vs C-D), stratified by: menopausal status (pre/post-menopause), use of hormonal therapy (yes/no), family history of breast cancer (yes/no).
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