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

NCT06846814 | Enrolling By Invitation

• 1 other identifier: T_4_2025
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Second look ultrasound; contrast enhanced mammography; breast cancer detection

Outcome Measures

Primary Outcomes (1)

• Detection Rate of Additional Lesions on CEM

  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 Outcomes (2)

• Concordance Between Imaging Findings and Histopathology

  Up to 3 months post-biopsy.

• Concordance Between Imaging Findings and Follow-Up Imaging

  6-12 months after the initial CEM examination

Interventions

CEM protocol DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Graziella di Grezia: lead
• Link Campus University: collaborator
• University of Campania Luigi Vanvitelli: collaborator

Study Sites (1)

University of Campania Luigi Vanvitelli

Naples, 80138, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Graziella Di Grezia, Medicine

  Link Campus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 26, 2025
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)