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

NCT06846814 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2025-02-26

No results posted yet for this study

Summary

This study investigates the utility of second-look ultrasound (US) following contrast-enhanced mammography (CEM) to characterize additional lesions detected during routine breast imaging.

Conditions

  • Breast Cancer Diagnosis
  • Breast Cancer Detection

Interventions

DIAGNOSTIC_TEST

CEM protocol

The intervention consists of Second-Look Ultrasound (SLUS) performed following Contrast-Enhanced Mammography (CEM) to further evaluate additional lesions detected during routine breast imaging. When CEM identifies additional or suspicious lesions not clearly characterized by mammography alone, targeted ultrasound is conducted to assess lesion morphology, vascularity, and acoustic characteristics. Radiologists with expertise in both CEM and ultrasound interpretation will perform SLUS to determine whether the lesions require biopsy, short-term follow-up, or no further action. Findings will be correlated with histopathological results (if biopsy is performed) or follow-up imaging to assess diagnostic accuracy.

Sponsors & Collaborators

  • Link Campus University

    collaborator OTHER

  • University of Campania Luigi Vanvitelli

    collaborator OTHER

  • Graziella di Grezia

    lead OTHER

Principal Investigators

  • Graziella Di Grezia, Medicine · Link Campus University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06846814 on ClinicalTrials.gov