Actively Recruiting
Non-inferiority Study of Contrast-enhanced Digital Mammography (CEDM) vs Magnetic Resonance Imaging (MRI) in Terms of Diagnostic Accuracy in Patients Undergoing Preoperative Staging of Established Invasive Breast Cancer
Led by Azienda Ospedaliera Universitaria Integrata Verona · Updated on 2025-07-17
216
Participants Needed
1
Research Sites
330 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliera Universitaria Integrata Verona
Lead Sponsor
G
GE Healthcare
Collaborating Sponsor
AI-Summary
What this Trial Is About
The general objective of the study is to verify the diagnostic accuracy of contrast-enhanced mammography (CEM) compared to breast magnetic resonance imaging in patients undergoing preoperative staging for breast neoformations that have already been diagnosed and in patients undergoing neoadjuvant chemotherapy. In addition to performing a preoperative breast resonance imaging, which is always performed in these patients, one contrast-enhanced mammography per patient is planned. In patients undergoing neoadjuvant chemotherapy, which usually undergo MRI examination at the beginning, mid-cycle and at the end of chemotherapy treatment, a CEM will also be acquired same way at the beginning, mid-cycle and at the end of chemotherapy treatment. The study requires, for the execution of the contrast-enhanced mammography exam, the administration of an iodinated contrast medium that is completely analogous to that used in computed tomography.
CONDITIONS
Official Title
Non-inferiority Study of Contrast-enhanced Digital Mammography (CEDM) vs Magnetic Resonance Imaging (MRI) in Terms of Diagnostic Accuracy in Patients Undergoing Preoperative Staging of Established Invasive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with confirmed invasive breast cancer (T1-2) in pre-hospitalization
- Age over 30 years
- BI-RADS mammography pattern greater than 1
- Signed informed consent for research participation
- No history of adverse reactions to iodinated or gadolinium contrast media
- Normal kidney function with eGFR over 30 mL/min within 3 months before contrast administration
You will not qualify if you...
- Women with breast implants
- Women under 30 years old
- Any contraindication to MRI exam
- Women with known BRCA1 or BRCA2 mutations
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ospedale Borgo Trento, AOUI Verona
Verona, Italy, Italy, 37138
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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