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Enrolling by Invitation

NCT Number: NCT06846814

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

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

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Key information

Conditions

Breast Cancer Diagnosis Breast Cancer Detection Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Campania Luigi Vanvitelli

Naples, 80138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Graziella di Grezia

Other

Collaborators

  • Link Campus University
  • University of Campania Luigi Vanvitelli

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 26, 2025
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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