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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06838117

Enrollment

213

Registered

2025-02-20

Start date

2022-05-01

Completion date

2025-02-28

Last updated

2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To Establish a Standardized Background Parenchimal Enhancement Classification System

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results