Non-inferiority Study of Mammography With the Contrast Medium (Contrast-enhanced Digital Mammography, CEDM) Versus Breast Magnetic Resonance (MRI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of the CEDM against breast MRI
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients undergoing preoperative staging and patients undergoing chemotherapy
All participants in the group 1 and 2 will undergo a routine clinical MRI followed by CEM during a scheduled visit.
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.
Intervention: breast-MRI and CEM (Other)
Outcomes
Primary Outcomes
Diagnostic accuracy of the CEDM against breast MRI
Time Frame: Time Frame: Up to 6 months from baseline imaging (MRI and CEDM)
The primary outcome is to assess 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 follow the Liu et al. method, accounting for dependent diagnostic testing.
Secondary Outcomes
- Inter-observer agreement(At baseline imaging (single time point))
- Tumor size and regression evaluation (neoadjuvant patients)(Up to 6 months per participant)