Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization

February 20, 2025 updated by: Graziella di Grezia
This study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The goal is to assess the diagnostic accuracy and clinical value of combining CEM with targeted ultrasound to improve lesion characterization and guide biopsy decisions.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Naples, Italy, 80138
        • University of Campania Luigi Vanvitelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women aged 18 years and older undergoing CEM as part of diagnostic or surveillance protocols.

Lesions detected by CEM that require additional characterization.

Description

INCLUSION CRITERIA:

  • Patients undergoing contrast-enhanced mammography for diagnostic or surveillance purposes.
  • Identification of additional lesions on CEM requiring further evaluation.
  • Ability to provide informed consent.

EXCLUSION CRITERIA:

  • Known breast cancer diagnosis without suspicion of additional lesions.
  • Contraindications to ultrasound or contrast agents.
  • Patients with incomplete imaging data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection Rate of Additional Lesions on CEM
Time Frame: Within 12 months of imaging assessment.
This measure evaluates the number of additional lesions identified on Contrast-Enhanced Mammography (CEM) that require further assessment through second-look ultrasound or biopsy.
Within 12 months of imaging assessment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance Between Imaging Findings and Histopathology
Time Frame: Up to 3 months post-biopsy.
This measure assesses the percentage of biopsied lesions in which imaging findings (from CEM and SLUS) correlate with the histopathological results
Up to 3 months post-biopsy.
Concordance Between Imaging Findings and Follow-Up Imaging
Time Frame: 6-12 months after the initial CEM examination
This measure evaluates the percentage of lesions that remain stable or resolve in follow-up imaging, confirming or refuting the initial CEM and ultrasound findings.
6-12 months after the initial CEM examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Graziella di Grezia

Collaborators

Link Campus University
University of Campania Luigi Vanvitelli

Investigators

  • Principal Investigator: Graziella Di Grezia, Medicine, Link Campus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

February 15, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T_4_2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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