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Clinical Trials in Italy / NCT07071272
Recruiting Not applicable

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 · tracked via the Priya Life Science Italy tracker
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Phase
Not applicable
Started
2020-09-01
Last updated
2025-07-17

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

breast-MRI and CEM

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

Study 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.

Eligibility

Sex
FEMALE
Min age
30 Years
Max age
—
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

Primary outcome measure(s)

  • Diagnostic accuracy of the CEDM against breast MRI — 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.

Trial sites (1)

FacilityCityRegionStatus
Ospedale Borgo Trento, AOUI Verona Verona Italy Recruiting

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Other trials for the same condition

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) Active, not recruiting
The OPBC-07/microNAC Study Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study Active, not recruiting
Music Therapy in Patients With Breast Cancer (IMPACT) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07071272 on ClinicalTrials.gov ↗ ← All trials in Italy