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Search / Trial 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

Launched by GRAZIELLA DI GREZIA · Feb 15, 2025

Trial Information

Current as of November 12, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This study is watching whether having denser breast tissue is linked to a higher level of background parenchymal enhancement (BPE) seen on contrast-enhanced mammography (CEM). In plain terms, researchers want to know if breasts that look denser on imaging also light up more when a contrast agent is used, and whether this relationship is real enough to be meaningful. They also aim to develop a standardized scale (the BCSS) to describe BPE so doctors report it in the same way in the future. The work uses past imaging from about 213 women who had CEM, standard mammography, and ultrasound at the Pellino Hospital in Brindisi, Italy, between May 2022 and June 2023, with analysis planned within about a year after the study finishes.

Who may be eligible and what to expect: the study looks at women 18 and older who had the required imaging (CEM, mammography, and ultrasound) and for whom BPE levels and breast density (BI-RADS classification) were recorded, with a complete imaging dataset available. Exclusions include a history of breast cancer treatment that could change BPE, incomplete data, or any reason a person cannot have contrast imaging. This is a retrospective study, meaning it analyzes existing records rather than asking people to enroll new participants or undergo additional procedures. There is no active treatment involved, and you don’t need to do anything now if you were not previously part of the dataset. The study is currently enrolling by invitation, with results expected after completion. Primary leadership is at Pellino Hospital, and the project is led by Graziella Di Grezia, with collaboration from Link Campus University and the University of Campania Luigi Vanvitelli.

Gender

FEMALE

Eligibility criteria

  • 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.

About Graziella Di Grezia

Graziella Di Grezia is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on integrity and ethical standards, the organization collaborates with healthcare professionals and institutions to conduct rigorous trials across various therapeutic areas. Graziella Di Grezia prioritizes patient safety and data integrity, leveraging cutting-edge methodologies and comprehensive monitoring to ensure the highest quality of clinical research. Their mission is to contribute to the development of effective treatments and enhance the understanding of medical conditions, ultimately benefiting patients and the broader healthcare community.

Locations

Brindisi, Italy

Patients applied

0 patients applied

Trial Officials

Graziella Di Grezia, Medicine and Surgery

Principal Investigator

Link Campus University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported