Breast density legislation: mandatory disclosure to patients, alternative screening, billing, reimbursement.
Kimberly M Ray, Elissa R Price, Bonnie N Joe
https://pubmed.ncbi.nlm.nih.gov/25615746Actively Recruiting
Age: 45Years - 75Years
FEMALE
ID07415499
Retrospective Study on Breast Density Impact During Mammographic Screening for Breast Cancer Diagnosis at ASL CN2
Led by Azienda Sanitaria Locale CN2 Alba-Bra · Updated on 2026-02-17
3300
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
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 software's 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 software's 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.
CONDITIONS
Brief Title
Breast Density Impact on Mammographic Screening for Breast Cancer Diagnosis
Who Can Participate
Age: 45Years - 75Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Women aged 45 to 75 years who underwent screening mammography at ASL CN2 between September 25, 2023, and May 3, 2024
- Participation in the "Prevenzione Serena" mammography screening program
- Signed informed consent or equivalent substitute declaration, when applicable
You will not qualify if you...
- History of mastectomy
- Presence of breast implants
- Presence of cardiac implantable devices such as pacemakers or loop recorders
- Cases where Insight BD software cannot be applied due to compression thickness below 15 mm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during routine mammographic screening
Diagnostic Evaluation
Duration - Approximately 7 months
Participants undergo routine mammographic screening to assess breast density and identify any need for second-level diagnostic examinations.
1 mammographic screening visit
Long-term Monitoring
Duration - Up to 2 years after screening period
Participants' screening data, including breast density and recall rates, are observed retrospectively to evaluate screening performance and associations with clinical factors.
No additional visits; data collection is retrospective
Trial Site Locations
Total: 1 location
1
SSD Fisica Sanitaria - Ospedale Michele e Pietro Ferrero di Verduno (CN) - ASL CN2
Verduno, Italy/CN, Italy, 12060
Actively Recruiting
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Research Team
F
Francesco Lucio, Principal Investigator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Dense Breast Legislation in the United States: State of the States.
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Christine N Damases, Patrick C Brennan, Claudia Mello-Thoms...
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https://pubmed.ncbi.nlm.nih.gov/25239205Measuring mammographic density: comparing a fully automated volumetric assessment versus European radiologists' qualitative classification.
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https://pubmed.ncbi.nlm.nih.gov/27011371