Ireland
--:--IST
Enrolling by invitation Observational

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

NCT06846814 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01-01
Last updated
2025-02-26

Condition(s) studied

Breast Cancer DiagnosisBreast Cancer Detection

Investigational drug(s) / intervention(s)

CEM protocol

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.

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Detection Rate of Additional Lesions on CEM — 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.

Trial sites (1)

FacilityCityRegionStatus
University of Campania Luigi Vanvitelli Naples Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06846814 on ClinicalTrials.gov ↗ ← All trials in Italy