From Variability to Standardization: The Impact of Breast Density on Background Parenchymal Enhancement in Contrast-Enhanced Mammography and the Need for a Structured Reporting System

This retrospective study includes 213 patients who underwent CEM, mammography (MG), and ultrasound (US) between May 2022 and June 2023 at the P.O. 'A. Perrino' Hospital, Brindisi. BPE was categorized into four levels (Minimal, Light, Moderate, and Marked), while breast density was rated according to the ACR BI-RADS (A-D) classification. A statistical analysis was performed to assess the correlation between BPE and breast density, supporting the development of the BPE-CEM Standard Scale (BCSS) to standardize reporting and improve interobserver agreement.

Study Overview

• Status: Enrolling by invitation
• Conditions: To Establish a Standardized Background Parenchimal Enhancement Classification System

• Study Type: Observational
• Enrollment (Estimated): 213

Contacts and Locations

Study Locations

• Italy
  • Brindisi, Italy
    • Pellino Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 years and older who underwent CEM for diagnostic or surveillance purposes.

Patients with recorded BPE levels and BI-RADS breast density classification.

Description

Inclusion Criteria:

Patients who underwent CEM, mammography, and ultrasound between May 2022 and June 2023.

Availability of BPE assessment and BI-RADS density classification.

Complete imaging dataset available for analysis.

Exclusion Criteria:

Patients with prior breast cancer treatment that could alter BPE.

Incomplete imaging data or missing classification values.

Contraindications to contrast-enhanced imaging.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Retrospective Cohort of Women Undergoing Contrast-Enhanced Mammography (CEM) for Diagnostic and Surv

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between breast density and background parenchymal enhancement (BPE) in CEM.	This outcome assesses whether increased breast density is associated with higher BPE levels and evaluates the statistical significance of the correlation.	Data analysis within 12 months of study completion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development and validation of the BPE-CEM Standard Scale (BCSS).	Establishing a structured lexicon for BPE classification and assessing its clinical utility.	Within 12 months of study completion.

Collaborators and Investigators

• Sponsor: Graziella di Grezia
• Collaborators: Link Campus University; University of Campania Luigi Vanvitelli
• Investigators: Principal Investigator: Graziella Di Grezia, Medicine and Surgery, Link Campus University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: T_5_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No