How breast density affects mammogram screening and follow-up
Official title: Retrospective Study on Patients Undergoing Mammographic Screening to Evaluate the Impact of Breast Density on Breast Cancer Diagnosis
Run by Azienda Sanitaria Locale CN2 Alba-Bra · NCT07415499 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 45 Years to 75 Years |
| Sex | Women only |
| Enrollment | 3300 (estimated) |
| Sponsor | Azienda Sanitaria Locale CN2 Alba-Bra Academic / other |
| Locations | 1 site (Verduno, Italy/CN) |
| Status | Recruiting |
| Started | January 12, 2026 |
| Main results expected | June 2026 |
| Study ends | September 2026 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT07415499 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.