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

NCT ID: NCT06846814

Last Updated: 2025-02-26

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Diagnosis Breast Cancer Detection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Link Campus University

OTHER

Sponsor Role collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role collaborator

Graziella di Grezia

OTHER

Sponsor Role lead

Responsible Party

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Graziella di Grezia

Principal Investigator

Responsibility Role SPONSOR_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

Site Status

Countries

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Italy

Other Identifiers

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T_4_2025

Identifier Type: -

Identifier Source: org_study_id

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