How breast density affects mammogram screening and follow-up
Retrospective Study on Patients Undergoing Mammographic Screening to Evaluate the Impact of Breast Density on Breast Cancer Diagnosis
This project will test whether women aged 45–75 with dense breasts have more recalls and additional diagnostic tests after routine mammograms than women with less dense breasts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3300 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | Female |
| Sponsor | Azienda Sanitaria Locale CN2 Alba-Bra Academic / other |
| Locations | 1 site (Verduno, Italy/CN) |
| Trial ID | NCT07415499 on ClinicalTrials.gov |
What this trial studies
This retrospective, monocentric study analyzes screening mammograms from women aged 45–75 who underwent routine screening at ASL CN2 between 25 September 2023 and 3 May 2024. Breast density will be categorized using BI-RADS A–D and the primary analysis will compare recall rates for second-level exams (ultrasound, MRI, etc.) between women with dense (C–D) versus non-dense (A–B) breasts. A secondary component performs an internal validation of the Insight BD automated density software using a dedicated mammographic phantom for technical repeatability and by comparing software-assigned BI-RADS categories with readings from two radiologists. The study will quantify how density influences screening performance metrics including recall rate, false positives, and potential masking of cancers within a real-world regional screening program.
Who should consider this trial
Good fit: Women aged 45–75 who had routine screening mammography at ASL CN2 between 25 September 2023 and 3 May 2024 and who can provide informed consent are the ideal candidates.
Not a fit: Women with prior mastectomy, breast implants, cardiac implantable devices, or cases where compression thickness is below 15 mm (preventing use of the automated software) are excluded and may not directly benefit from this study.
Why it matters
Potential benefit: If successful, the findings could help identify women who may benefit from supplemental imaging or tailored screening intervals, potentially reducing missed cancers and unnecessary procedures.
How similar studies have performed: Large prior studies have consistently shown that dense breasts reduce mammography sensitivity and increase recall rates, and automated density tools have shown promising agreement with radiologist ratings, so this work builds on established evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Verduno, Italy/CN
- SSD Fisica Sanitaria - Ospedale Michele e Pietro Ferrero di Verduno (CN) - ASL CN2 — Verduno, Italy/CN, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Lucio, Principal Investigator
- Email: flucio@aslcn2.it
- Phone: +39.0172.1408486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.