NCT06846814

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Graziella di Grezia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer Diagnosis
• Breast Cancer Detection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-31
• Completion: 2026-01-31
• First posted: 2025-02-26
• Last updated: 2025-02-26

Locations

1 site across 1 country: Italy