Clinical trial · Observational
Breast Density Impact on Mammographic Screening for Breast Cancer Diagnosis
Retrospective Study on Patients Undergoing Mammographic Screening to Evaluate the Impact of Breast Density on Breast Cancer Diagnosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Screening | — | UNRESOLVED | — |
| Breast Cancer Screening and Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention is administered. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Screening cohort
- description
- 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.
- interventionNames
- Other: No intervention is administered.
Primary outcomes (1)
- measure
- Recall Rate for Second-Level Examinations by BI-RADS Breast Density Category
- timeFrame
- September 2023 - May 2024
- description
- 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.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDRay KM, Price ER, Joe BN. Breast density legislation: mandatory disclosure to patients, alternative screening, billing, reimbursement. AJR Am J Roentgenol. 2015 Feb;204(2):257-60. doi: 10.2214/AJR.14.13558. PMID 25615746
- BACKGROUNDDehkordy SF, Carlos RC. Dense Breast Legislation in the United States: State of the States. J Am Coll Radiol. 2016 Nov;13(11S):R53-R57. doi: 10.1016/j.jacr.2016.09.027. PMID 27814815
- BACKGROUNDDamases CN, Brennan PC, Mello-Thoms C, McEntee MF. Mammographic Breast Density Assessment Using Automated Volumetric Software and Breast Imaging Reporting and Data System (BIRADS) Categorization by Expert Radiologists. Acad Radiol. 2016 Jan;23(1):70-7. doi: 10.1016/j.acra.2015.09.011. Epub 2015 Oct 26. PMID 26514436
- BACKGROUNDPesce K, Tajerian M, Chico MJ, Swiecicki MP, Boietti B, Frangella MJ, Benitez S. Interobserver and intraobserver variability in determining breast density according to the fifth edition of the BI-RADS(R) Atlas. Radiologia (Engl Ed). 2020 Nov-Dec;62(6):481-486. doi: 10.1016/j.rx.2020.04.006. Epub 2020 May 31. English, Spanish. PMID 32493654
- BACKGROUNDSheehan J. Brain fragments: Leksell's autobiography newly translated to English. J Neurooncol. 2022 Apr;157(2):383. doi: 10.1007/s11060-022-03968-y. Epub 2022 Mar 29. No abstract available. PMID 35348987
- BACKGROUNDMartinez-Navarro B, Sanchis R, Asedegbega-Nieto E, Solsona B, Ivars-Barcelo F. (Ag)Pd-Fe3O4 Nanocomposites as Novel Catalysts for Methane Partial Oxidation at Low Temperature. Nanomaterials (Basel). 2020 May 21;10(5):988. doi: 10.3390/nano10050988. PMID 32455643
- BACKGROUNDZimri K, Hesseling AC, Godfrey-Faussett P, Schaaf HS, Seddon JA. Why do child contacts of multidrug-resistant tuberculosis not come to the assessment clinic? Public Health Action. 2012 Sep 21;2(3):71-5. doi: 10.5588/pha.12.0024.