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

NCT07071272 | Recruiting

• 1 other identifier: CEDM-VR-2803CESC
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

CEM; breast cancer; breast MR

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of the CEDM against breast MRI

  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.

  Time Frame: Up to 6 months from baseline imaging (MRI and CEDM)

Secondary Outcomes (2)

• Inter-observer agreement

  At baseline imaging (single time point)

• Tumor size and regression evaluation (neoadjuvant patients)

  Up to 6 months per participant

Study Arms (1)

Patients undergoing preoperative staging and patients undergoing chemotherapy

EXPERIMENTAL

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.

Other: breast-MRI and CEM

Interventions

breast-MRI and CEM OTHER

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

Patients undergoing preoperative staging and patients undergoing chemotherapy

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead
• GE Healthcare: collaborator

Study Sites (1)

Ospedale Borgo Trento, AOUI Verona

Verona, Italy, 37138, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

omega-Chloroacetophenone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetophenones; Ketones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: July 17, 2025
• Study Start: September 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-05

Locations

IT (1)