Brief Summary

This is a multi-center, randomized, open-label clinical trial that will enroll 1302 adult patients with non-palpable breast lesions. Participant eligible for the study will be randomized in a 1:1:1 ratio to one of the pre-surgery lesion localization: IOUS HydroMark™ (experimental arm A), magnetic Sirius Pintuition Seed® (experimental arm B) and the wire localization technique (control arm). The randomization will be stratified by lesion type (solid non-palpable (type B); non-solid non-palpable (e.g., microcalcification clusters, architectural distortive areas) (type C); post-NACT residual lesions (type D), and clinical center.

Conditions

• Breast Cancer
• Breast-Conserving Surgery

Intervention / Treatment

• Procedure: IOUS HydroMark™
• Procedure: Magnetic Sirius Pintuition Seed®
• Procedure: Wire localization (WL)

Primary Outcome Measures

• Involved resection margins. (Through study completion, an average of 2 years)
  Compare the efficacy of the IOUS HydroMark™ and magnetic Sirius Pintuition Seed® versus the wire localization technique in terms of involved resection margins. Positive margin rate, defined as the number of patients with ink on invasive cancer or ductal carcinoma in situ with a resection margin \< 2mm out of the total number of enrolled patients.

Countries

Italy

Locations and Investigators

• Azienda Ospedaliera San Giovanni Addolorata, Roma, Italy
  • Lucio Fortunato, MD
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy
  • Gianluca Franceschini, MD
• AOU Policlinico di Modena, Modena, Italy
  • Enza Palma, MD
• ASL2 Abruzzo, Ospedale "Gaetano Bernabeo", Ortona, Ortona, Italy
  • Simona Grossi, MD
• Istituto Oncologico Veneto IRCCS, Padova, Italy
  • Massimo Ferrucci, MD PhD
  • Massimo Ferrucci, MD PhD (Principal Investigator)

Study Officials

• Massimo Ferrucci, MD PhD (Principal Investigator) — Veneto Institute of Oncology IRCCS