Comparing contrast-enhanced mammography and MRI for preoperative breast cancer staging
Official title: Non-inferiority Study of Mammography With the Contrast Medium (Contrast-enhanced Digital Mammography, CEDM) Versus Breast Magnetic Resonance (MRI)
Run by Azienda Ospedaliera Universitaria Integrata Verona · NCT07071272 · Data updated 2026-11-12
This test compares contrast-enhanced mammography (CEM) with breast MRI to see if CEM works as well for preoperative staging in women with diagnosed invasive breast cancer, including those receiving neoadjuvant chemotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years and up |
| Sex | Women only |
| Enrollment | 216 (estimated) |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Verona, Italy) |
| Status | Recruiting |
| Started | September 1, 2020 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | July 17, 2025 |
| Trial ID | NCT07071272 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women over age 30 with biopsy-proven invasive breast cancer (T1-2) who are undergoing preoperative staging or neoadjuvant chemotherapy, have BI-RADS mammography pattern >1, can receive iodinated contrast, and have adequate renal function are ideal candidates.
✕Probably not a fit
Patients unlikely to benefit include women under 30, those with breast implants, known BRCA1/BRCA2 mutation carriers, those with significant renal impairment or a history of severe contrast reaction, and anyone with contraindications that would preclude participation per the trial criteria.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective non-inferiority study enrolling about 216 women with confirmed invasive breast cancer, split between those undergoing standard preoperative staging and those receiving neoadjuvant chemotherapy. All participants will receive both contrast-enhanced digital mammography (CEM) and breast MRI, with histology from biopsy or surgery used as the reference standard. Patients on neoadjuvant chemotherapy will have CEM and MRI at baseline, mid-treatment, and end of treatment to compare temporal response assessment. The CEM exams require intravenous iodinated contrast and are compared to MRI for sensitivity, specificity, PPV, NPV, and lesion size estimation.
Why it matters
Potential benefit: If CEM proves non-inferior to MRI, patients could have a faster, lower-cost imaging option for staging that may also help when MRI is impractical or unavailable.
How similar studies have gone: Preliminary and smaller studies have suggested CEM can match or exceed MRI for some measures such as specificity and lesion sizing, but large prospective non-inferiority data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * women in pre-hospitalization with already established invasive breast cancer (T1-2) * over the age of 30 * with BI-RADS mammography pattern\> 1 * Written and signed informed consent for research * Negative history of adverse events to the use of iodinated and chelated contrast media of gadolinium * No significant renal impairment (EGFR\> 30 mL / min within three months before administration of the iodinated contrast medium) Exclusion Criteria: * women with breast implants * women under the age of 30 * Any contraindication to performing the MRI exam * Women with known BRCA 1 and BRCA 2 mutation
Where it's running
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Ospedale Borgo Trento, AOUI Verona
Verona, Italy, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.