Retrospective Study on Patients Undergoing Mammographic Screening to Evaluate the Impact of Breast Density on Breast Cancer Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,300
- 试验地点
- 1
- 主要终点
- Recall Rate for Second-Level Examinations by BI-RADS Breast Density Category
研究概览
简要总结
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.
详细描述
This retrospective, monocentric, observational study investigates the impact of breast density on mammographic screening performance in the regional program "Prevenzione Serena," implemented at ASL CN2 (Piedmont, Italy). The primary objective is to evaluate the association between BI-RADS breast-density categories and the frequency of recalls for second-level diagnostic examinations among women aged 45-75 undergoing screening mammography between 25 September 2023 and 3 May 2024.
Breast density is a known factor that can reduce the sensitivity of mammography. Dense fibroglandular tissue appears radiopaque and may mask suspicious lesions, leading to false-negative or false-positive examinations. Women with dense breasts (BI-RADS categories C-D) also have an independently increased risk of breast cancer. For these reasons, the study aims to characterize how breast density influences recall rates, diagnostic appropriateness, and overall screening performance in a real-world population.
A secondary goal is the internal validation of Insight BD, an automated breast-density assessment software integrated into the Siemens Mammomat Revelation mammography system used at ASL CN2. The validation includes:
- Technical validation using a dedicated mammographic phantom with known density values to determine measurement accuracy and repeatability;
- Diagnostic validation through comparison between the BI-RADS density category assigned by the software and those assigned by two radiologists (one expert, one non-expert).
The study will also examine associations between breast density and key clinical factors, including menopausal status, family history of breast cancer, and systemic hormone therapy. Furthermore, the frequency of false-positive recalls (additional testing without a final diagnosis of cancer) will be assessed, given their clinical, psychological, and organizational implications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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,
- •Signed informed consent or equivalent substitute declaration, when applicable.
排除标准
- •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.
研究组 & 干预措施
Screening cohort
Women aged 45-75 who underwent routine mammographic screening within the "Prevenzione Serena" program at ASL CN2 between September 2023 and May 2024. Breast density (BI-RADS A-D) will be evaluated, along with recall rates, false-positive findings, and comparisons of automated breast-density assessment (Insight BD) with radiologist readings. No interventions are administered; data are collected retrospectively from clinical records.
干预措施: No intervention is administered. (Other)
结局指标
主要结局
Recall Rate for Second-Level Examinations by BI-RADS Breast Density Category
时间窗: September 2023 - May 2024
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.
次要结局
- Technical Performance of Insight BD: Accuracy and Repeatability on Breast Density Phantom(September 2023 - May 2024)
- Concordance Between Insight BD BI-RADS Classification and Radiologist Assessment(September 2023 - May 2024)
- Recall Rate for Second-Level Examinations in Negative Mammographic Screens by BI-RADS Density(September 2023 - May 2024)
- Distribution of Breast Density by Menopausal Status, Hormonal Therapy, and Family History(September 2023 - May 2024)