Breast Density Impact on Mammographic Screening for Breast Cancer Diagnosis (SINATRA)

February 16, 2026 updated by: Azienda Sanitaria Locale CN2 Alba-Bra

Retrospective Study on Patients Undergoing Mammographic Screening to Evaluate the Impact of Breast Density on Breast Cancer Diagnosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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:

  1. Technical validation using a dedicated mammographic phantom with known density values to determine measurement accuracy and repeatability;
  2. 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.

The study aims to characterize density-related patterns in screening performance, quantify false-positive recalls, and contribute evidence to support future updates to breast-screening guidelines and potential personalized screening strategies, especially for women with dense breast tissue.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Francesco Lucio, Principal Investigator
  • Phone Number: +39.0172.1408486
  • Email: flucio@aslcn2.it

Study Locations

  • Italy
    • Italy/CN
      • Verduno, Italy/CN, Italy, 12060
        • Recruiting
        • SSD Fisica Sanitaria - Ospedale Michele e Pietro Ferrero di Verduno (CN) - ASL CN2
        • Contact:
          • Francesco Lucio, Principal Investigator
          • Phone Number: +39.0172.1408486
          • Email: flucio@aslcn2.it
        • Sub-Investigator:
          • Anna Sardo
        • Sub-Investigator:
          • Michele Lo Bello
        • Sub-Investigator:
          • Francesco Testa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include women aged 45 to 75 years who participated in the "Prevenzione Serena" mammography screening program and underwent screening mammography at ASL CN2 using a Siemens MAMMOMAT Revelation mammography system between September 25, 2023, and May 3, 2024.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: No intervention is administered.
No intervention is administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recall Rate for Second-Level Examinations by BI-RADS Breast Density Category
Time Frame: 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.
September 2023 - May 2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical Performance of Insight BD: Accuracy and Repeatability on Breast Density Phantom
Time Frame: September 2023 - May 2024
Evaluation of the volumetric breast density percentage produced by Insight BD on a standardized phantom, assessing measurement accuracy compared with the reference phantom values and repeatability across repeated acquisitions.
September 2023 - May 2024
Concordance Between Insight BD BI-RADS Classification and Radiologist Assessment
Time Frame: September 2023 - May 2024

Diagnostic agreement between Insight BD BI-RADS breast density classification and radiologist assessments. The outcome includes:

  • Percent agreement with the expert radiologist (primary reference).
  • Percent agreement with a non-expert radiologist to evaluate the tool's impact on less-experienced readers.
September 2023 - May 2024
Recall Rate for Second-Level Examinations in Negative Mammographic Screens by BI-RADS Density
Time Frame: September 2023 - May 2024
Proportion of women recalled for second-level diagnostic examinations among those with a negative screening mammogram, stratified by BI-RADS breast density categories (A, B, C, D) and by dichotomized density groups (A-B vs C-D).
September 2023 - May 2024
Distribution of Breast Density by Menopausal Status, Hormonal Therapy, and Family History
Time Frame: September 2023 - May 2024

Proportion of participants in each BI-RADS breast density category (A, B, C, D), and in dichotomized density groups (A-B vs C-D), stratified by:

menopausal status (pre/post-menopause), use of hormonal therapy (yes/no), family history of breast cancer (yes/no).
September 2023 - May 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Sanitaria Locale CN2 Alba-Bra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SINATRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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