Comparing contrast-enhanced mammography and MRI for preoperative breast cancer staging
Non-inferiority Study of Mammography With the Contrast Medium (Contrast-enhanced Digital Mammography, CEDM) Versus Breast Magnetic Resonance (MRI)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 30 Years and up |
| Sex | Female |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Verona, Italy) |
| Trial ID | NCT07071272 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Verona, Italy
- Ospedale Borgo Trento, AOUI Verona — Verona, Italy, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.