RecruitingNot ApplicableNCT07071272

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

Non-inferiority Study of Mammography With the Contrast Medium (Contrast-enhanced Digital Mammography, CEDM) Versus Breast Magnetic Resonance (MRI)


Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Enrollment

216 participants

Start Date

Sep 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study compares contrast-enhanced digital mammography (CEDM — a special type of mammogram using contrast dye) versus MRI for staging newly diagnosed breast cancer before surgery. The goal is to find out if CEDM is as accurate as MRI but faster and less costly. **You may be eligible if...** - You are a woman 30 or older - You have already been diagnosed with invasive breast cancer (T1 or T2 stage) - You are about to have pre-surgical planning (staging) - You have no history of allergic reactions to contrast dyes (both iodine-based and gadolinium-based) - You have normal kidney function **You may NOT be eligible if...** - You have had a prior allergic reaction to contrast agents - Your kidneys are not functioning well enough - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERbreast-MRI and CEM

Participants will undergo a breast MRI followed by CEM for local breast cancer staging


Locations(1)

Ospedale Borgo Trento, AOUI Verona

Verona, Italy, Italy

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NCT07071272


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