Contrast-Enhanced Spectral Mammography (CESM) (CESM)
The Role of Contrast-Enhanced Spectral Mammography (CESM) in the Diagnostic Process of Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Enrico Cassano, MD
- Phone Number: +390257489410
- Email: enrico.cassano@ieo.it
Study Contact Backup
- Name: Luca Nicosia
- Phone Number: +390257489410
- Email: luca.nicosia@ieo.it
Study Locations
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-
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Milan, Italy, 20141
- Recruiting
- Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS
-
Contact:
- Luca Nicosia, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Contrast Enhanced Mammography
Patients underwent Contrast Enhanced Mammography
|
Contrast Enhanced Mammography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of negative predictive value (NPV) of the CEM
Time Frame: 1 month
|
Assessment of diagnostic accuracy of CEM in dense breasts considering as reference the classification obtained with VABB.
Negative predictive value will be expressed as the proportion of patients classified as having no evidence of disease or Ductal Carcinoma In Situ (DCIS) at surgery among all patients with absence of contrast uptake at CEM
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of sensitivity of CEM
Time Frame: 1 month
|
Sensitivity will be expressed as the proportion of patients classified as positive with CEM, among all patients with malignant tumors classified with VABB (true positives)
|
1 month
|
|
Evaluation of specificity of CEM
Time Frame: 1 month
|
Specificity will be expressed as the proportion of patients classified as negative with CEM, among all patients with benign tumors classified with VABB (true negatives)
|
1 month
|
|
Positive Predictive Value (PPV) of CEM
Time Frame: 1 month
|
The positive predictive value will be expressed as the proportion of patients with malignant tumors classified with VABB among all patients classified as positive with CEM
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Enrico Cassano, MD, European Institute of Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IEO 960
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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