Contrast-Enhanced Spectral Mammography (CESM)

NCT ID: NCT06311695

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 263 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2025-12-31

Brief Summary

The study's objective is to compare the diagnostic accuracy of the contrast-enhanced mammography (CEM) , considering as reference the classification obtained with Vacuum Assisted Breast Biopsy (VABB).

Detailed Description

Breast cancer is the most diagnosed cancer in women and is one of the leading causes of morbidity and death from malignancy.

Improvement in survival and quality of life of patients with breast malignancies depends on the ability of imaging to diagnose the neoplasm in its early stages.

The main focus of imaging applied to the study of the breast is to obtain a good balance between the number of false positives and false negatives in the prediction of malignancy: good diagnostic performance should be achieved in identifying even small and insidious neoplasms without requiring excessive examinations for benign findings.

The main diagnostic method of screening for breast malignancy still remains mammography also considering its quick execution and low cost: however as is well known the diagnostic performance of mammography is highly impaired, in patients with dense breasts. The reduced sensitivity of mammography in women with dense breasts can result in a significant underdiagnosis rate, failing to prevent death due to breast cancer in a non-negligible number of women. The sensitivity of mammography is reported in the literature as between 62-68% in dense breasts: such performance is far too low to ensure adequate support in the management of breast malignancy; supplemental screening should be recommended in women with dense breasts.

For this purpose, a diagnostic technique called contrast-enhanced mammography (CEM) has been developed in recent years: CEM is based on the use of an iodinated contrast medium to assess the vascularity of any breast lesions and its first use was approved in 2011 by the food and drug administration (FDA).

The diagnostic performance of CEM in detecting and predicting the malignancy of breast lesions has been evaluated in many studies that have shown very promising result: CEM seems to provide excellent performance, particularly where conventional diagnostic methods seem to be struggling: the low sensitivity of mammography in dense breasts; the high operator dependence of breast ultrasound; the high cost, the high number of false positives and the time required to perform Magnetic Resonance Imaging (MRI).

The purpose of this studt is to assess the diagnostic performance of recombined CEM image, in predicting malignancy of breast lesions in a population mainly represented by patients with dense breasts.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Contrast Enhanced Mammography

Patients underwent Contrast Enhanced Mammography

Group Type: EXPERIMENTAL

Contrast Enhanced Mammography

Intervention Type: DEVICE

Contrast Enhanced Mammography

Interventions

Contrast Enhanced Mammography

Contrast Enhanced Mammography

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with breast lesions, who underwent bilateral CEM
• Histological assessment

Exclusion Criteria

• The subject is known to have risks of adverse effects with iodine contrast agents
• The subject has breasts too large to be adequately positioned on Full field digital mammography (FFDM) digital receptor without anatomical cut off during an FFDM examination

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrico Cassano, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Enrico Cassano, MD

Role: CONTACT

enrico.cassano@ieo.it

+390257489410

Luca Nicosia

Role: CONTACT

luca.nicosia@ieo.it

+390257489410

Facility Contacts

Luca Nicosia, MD

Role: primary

Other Identifiers

IEO 960

Identifier Type: -

Identifier Source: org_study_id