Second-Look Ultrasound Post Contrast-Enhanced Mammography for Additional Lesions Characterization
NCT ID: NCT06846814
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
350 participants
OBSERVATIONAL
2025-01-01
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Identification of additional lesions on CEM requiring further evaluation.
* Ability to provide informed consent.
Exclusion Criteria
* Contraindications to ultrasound or contrast agents.
* Patients with incomplete imaging data.
18 Years
FEMALE
No
Sponsors
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Link Campus University
OTHER
University of Campania Luigi Vanvitelli
OTHER
Graziella di Grezia
OTHER
Responsible Party
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Graziella di Grezia
Principal Investigator
Principal Investigators
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Graziella Di Grezia, Medicine
Role: PRINCIPAL_INVESTIGATOR
Link Campus University
Locations
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University of Campania Luigi Vanvitelli
Naples, , Italy
Countries
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Other Identifiers
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T_4_2025
Identifier Type: -
Identifier Source: org_study_id
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