Clinical trial NCT06311695: Contrast-Enhanced Spectral Mammography (CESM)
Official title: The Role of Contrast-Enhanced Spectral Mammography (CESM) in the Diagnostic Process of Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: mammography
enhancement
Contrast Enhanced Mammography
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 263
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluation of negative predictive value (NPV) of the CEM
timeFrame: 1 month
Secondary outcomes:
measure: Evaluation of sensitivity of CEM
timeFrame: 1 month
measure: Evaluation of specificity of CEM
timeFrame: 1 month
measure: Positive Predictive Value (PPV) of CEM
timeFrame: 1 month
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS
Study officials:
affiliation: European Institute of Oncology
name: Enrico Cassano, MD
role: PRINCIPAL_INVESTIGATOR
References: