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

NCT ID: NCT06838117

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

213 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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To Establish a Standardized Background Parenchimal Enhancement Classification System

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Graziella di Grezia

OTHER

Sponsor Role lead

Link Campus University

OTHER

Sponsor Role collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role collaborator

Responsible Party

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Graziella di Grezia

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Graziella Di Grezia, Medicine and Surgery

Role: PRINCIPAL_INVESTIGATOR

Link Campus University

Locations

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Pellino Hospital

Brindisi, , Italy

Site Status

Countries

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Italy

Other Identifiers

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T_5_2025

Identifier Type: -

Identifier Source: org_study_id

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