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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: breast-MRI and CEM.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 30 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Non-inferiority Study of Mammography With the Contrast Medium (Contrast-enhanced Digital Mammography, CEDM) Versus Breast Magnetic Resonance (MRI)
Overview
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.
Detailed description
This is a monocentric, prospective, experimental non-inferiority study evaluating the diagnostic performance of Contrast-Enhanced Digital Mammography (CEDM/CEM) compared to Breast Magnetic Resonance Imaging (MRI) in the preoperative assessment and staging of breast cancer.
MRI, recognized for its high sensitivity and three-dimensional visualization capabilities without ionizing radiation, is often used in specialized centers for detailed staging. However, it suffers from practical limitations including high cost, long exam duration (\~7-10 minutes), and cost-effective. Preliminary studies suggest its diagnostic accuracy may be comparable to, or even better than, MRI, especially regarding specificity and lesion size estimation. Furthermore, CEM can be used in patients with contraindications to MRI, including those with pacemakers, cochlear implants, or severe claustrophobia.
The study will enroll approximately 216 patients up to December 2025, divided in tho groups: 108 patients with already confirmed invasive breast cancer undergoing preoperative staging; 108 patients scheduled for neoadjuvant chemotherapy followed by surgery.
CEM and MRI will be performed for all enrolled participants. Histological examination of biopsy or surgical specimens will serve as the reference standard for evaluating diagnostic performance.
The primary outcome is to determine diagnostic accuracy (including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV)) of CEDM versus MRI, using histopathology as the gold standard. A non-inferiority margin (Δ) of 15% is defined. The non-inferiority hypothesis will be tested using paired binary outcomes, and sample size calculations for groups 1 and 2, accounting for dependent diagnostic testing.
The secondary endpoint are:
* evaluating interobserver agreement between radiologists interpreting CEDM (Cohen's kappa and intraclass correlation coefficients). * comparison of lesion size estimations and regression evaluations in patients undergoing neoadjuvant chemotherapy at baseline (T0), 3 months (T3), and 6 months (T6).
Descriptive statistics will summarize demographic and clinical characteristics. For hypothesis testing, paired comparisons will be used: Student's t-test or Wilcoxon test for continuous variables; McNemar test or Fisher's exact test for categorical variables. Pearson correlation coefficients will assess the relationship between imaging measurements and histology. Diagnostic accuracy comparisons will assess the lower bound of the 95% confidence interval against the non-inferiority threshold.
Participants must be women over 30 years of age with a BI-RADS mammographic pattern \>1, scheduled for a diagnostic MRI and meeting one of the five group classifications. Key exclusion criteria include: breast implants, known BRCA1 or BRCA2 mutations, contraindications to MRI, or impaired renal function (eGFR \<30 mL/min). All participants must provide informed consent.
Participants will undergo a routine clinical MRI followed by CEDM during a scheduled visit. Imaging will be interpreted independently by two radiologists, blinded to each other's findings, with subsequent consensus reporting. Pseudonymized data will be recorded, including imaging findings, histological results, and any adverse reactions to contrast agents.
In group 2 (neoadjuvant chemotherapy), patients will also undergo interim imaging with both MRI and CEDM at 3 and 6 months to assess treatment response.
Interventions
- Other breast-MRI and CEM
Participants will undergo a breast MRI followed by CEM for local breast cancer staging
Primary outcome measures
- Diagnostic accuracy of the CEDM against breast MRI [Time frame: Time Frame: Up to 6 months from baseline imaging (MRI and CEDM)]
Secondary outcome measures (2)
- Inter-observer agreement [Time frame: At baseline imaging (single time point)]
- Tumor size and regression evaluation (neoadjuvant patients) [Time frame: Up to 6 months per participant]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Ospedale Borgo Trento, AOUI Verona — Verona
Identifiers
NCT: NCT07071272 · CEDM-VR-2803CESC