---
title: "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
overall_status: ENROLLING_BY_INVITATION
sponsor: Graziella di Grezia
study_type: OBSERVATIONAL
primary_condition: To Establish a Standardized Background Parenchimal Enhancement Classification System
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06838117.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06838117"
ct_last_update_post_date: 2025-02-21
last_seen_at: "2026-05-12T06:02:24.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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](https://clinicaltrials.gov/study/NCT06838117)

## Key Facts

- **Status:** ENROLLING_BY_INVITATION
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 213
- **Lead Sponsor:** Graziella di Grezia
- **Collaborators:** Link Campus University, University of Campania Luigi Vanvitelli
- **Conditions:** To Establish a Standardized Background Parenchimal Enhancement Classification System
- **Start Date:** 2022-05-01
- **Completion Date:** 2025-02
- **CT.gov Last Update:** 2025-02-21

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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.
```

## Arms

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

## Primary Outcomes

- **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

- **Development and validation of the BPE-CEM Standard Scale (BCSS).** _(time frame: Within 12 months of study completion.)_

## Locations (1)

- Pellino Hospital, Brindisi, Italy

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pellino hospital|brindisi||italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06838117.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06838117*  
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