Breast Arterial Calcifications as an Imaging Biomarker of Cardiovascular Risk

NCT07156006 | Terminated

• 2 other identifiers: BAKER90/INT/2020
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess if there is an association between the presence of BAC and traditional cardiovascular risk factors and validate a Convolutional Neural Network (CNN) for the automatic segmentation of Breast Arterial Calcifications (BAC) in mammographic images. This study focuses on understanding the potential of BAC as an imaging biomarker for cardiovascular risk. The main questions it aims to answer are:

• Is there an association between the presence of BAC and traditional cardiovascular risk factors?
• Can a CNN accurately segment BAC in mammographic images?
• What is the correlation between BAC and White Matter Hyperintensities (WMH) detected through brain MRI? Participants in this study will be individuals who undergo mammographic screening. The main tasks participants will be asked to do include providing consent for participation and having mammographic images and a blood sample taken. The study will use a comparison group, comparing individuals with BAC to those without BAC, to assess potential effects on cardiovascular risk.

Conditions

Breast; Cardiovascular Calcification

Outcome Measures

Primary Outcomes (1)

• Association Between BAC and Cardiovascular Risk Factors

  Methodology: This aspect of the study aims to assess the association between the burden of BAC and traditional cardiovascular risk factors. Parametric and non-parametric tests will be employed to evaluate differences in BAC burden based on the presence or absence of traditional cardiovascular and gynecological risk factors. Implications: A positive association between BAC burden and cardiovascular risk factors may emphasize the potential of BAC as a biomarker for cardiovascular risk.

  One observation at the time of the mammography examination. Total time frame: 1 day.

Secondary Outcomes (1)

• Diagnostic Performance of CNN Detection and Quantification of BAC on Mammograms

  One observation at the time of the mammography examination. Total time frame: 1 day.

Study Arms (2)

BAC Group

Outpatients presenting in our department for annual mammography will be screened and selected for BAC presence. Mammographic Imaging: Participants will undergo mammographic imaging using a digital full-field mammography system, following standard clinical practices. The acquired mammographic images will serve as the basis for the development and testing of the Convolutional Neural Network (CNN) for Breast Arterial Calcifications (BAC) segmentation. Venous Blood Sample Collection: For each participants, a venous blood sample will be collected and traditional cardiovascular risk factors (such as age, hypertension, hyperlipidemia) will be recorded.

Diagnostic Test: Mammography

Control Group

Outpatients presenting in our department for annual mammography will be screened and matched for age and breast density to BAC Group. Mammographic Imaging: Participants will undergo mammographic imaging using a digital full-field mammography system, following standard clinical practices. The acquired mammographic images will serve as the basis for the development and testing of the Convolutional Neural Network (CNN) for Breast Arterial Calcifications (BAC) segmentation. Venous Blood Sample Collection: For each participants, a venous blood sample will be collected and traditional cardiovascular risk factors (such as age, hypertension, hyperlipidemia) will be recorded.

Diagnostic Test: Mammography

Interventions

Mammography DIAGNOSTIC_TEST

Participants will undergo mammographic imaging using a digital full-field mammography system, following standard clinical practices and blood sampling.

Also known as: Blood test

BAC Group; Control Group

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of women aged more than 40 years who have consented to undergo mammography screening. Participants will be recruited from individuals attending mammography screening programs at our institute.

You may qualify if:

• Female participants. Consent to undergo mammography screening. Agreement to participate in brain MRI for a subset of the study.

You may not qualify if:

• Male participants. Age below 40. Inability or unwillingness to undergo mammography screening. Contraindications for brain MRI, including the presence of pacemaker, intracranial ferromagnetic vascular clips, intraocular metallic fragments, severe claustrophobia, inability to maintain a supine position, involuntary movements, or pregnancy.
• Known history of breast cancer. Previous reductive breast surgery.

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Location

MeSH Terms

Interventions

Mammography; Hematologic Tests

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Clinical Laboratory Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: September 4, 2025
• Study Start: September 11, 2020
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)