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OpenTrials
Enrolling by Invitation

NCT Number: NCT06838117

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.

Enrolling by Invitation

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Key information

Conditions

To Establish a Standardized Background Parenchimal Enhancement Classification System

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Pellino Hospital

Brindisi, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Correlation between breast density and background parenchymal enhancement (BPE) in CEM.

    Time frame: 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 outcomes

  1. Development and validation of the BPE-CEM Standard Scale (BCSS).

    Time frame: Within 12 months of study completion.

    Establishing a structured lexicon for BPE classification and assessing its clinical utility.

Sponsors and collaborators

Lead sponsor

Graziella di Grezia

Other

Collaborators

  • Link Campus University
  • University of Campania Luigi Vanvitelli

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.