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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

G

Graziella di Grezia

Status

Invitation-only

Conditions

To Establish a Standardized Background Parenchimal Enhancement Classification System

Study type

Observational

Funder types

Other

Identifiers

NCT06838117
T_5_2025

Details and patient eligibility

About

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.

Enrollment

213 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

213 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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