Enrolling by invitation NCT06846814
Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CEM protocol.
- Who it may be relevant to
- Registry conditions: Breast Cancer Diagnosis, Breast Cancer Detection. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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 determin
Primary outcome measures
- Detection Rate of Additional Lesions on CEM [Time frame: Within 12 months of imaging assessment.]
Secondary outcome measures (2)
- Concordance Between Imaging Findings and Histopathology [Time frame: Up to 3 months post-biopsy.]
- Concordance Between Imaging Findings and Follow-Up Imaging [Time frame: 6-12 months after the initial CEM examination]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- University of Campania Luigi Vanvitelli — Naples
Identifiers
NCT: NCT06846814 · T_4_2025