Breast Density Impact on Mammographic Screening for Breast Cancer Diagnosis
Recruiting · NCT07415499 · Observational (researchers observe without assigning treatment) · Lead sponsor: Azienda Sanitaria Locale CN2 Alba-Bra
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- SSD Fisica Sanitaria - Ospedale Michele e Pietro Ferrero di Verduno (CN) - ASL CN2 - Verduno, Italy/CN, Italy