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.
Patients with non-palpable breast cancer candidate for breast-conserving surgery;
Female patients;
Patients aged ≥ 18 years;
Patients with histologic diagnosis of cT1-T2 invasive BC or ductal carcinoma in situ;
Pregnancy or lactation;
Patients with locally advanced disease or metastatic disease;
Patients with palpable breast carcinoma;
Patients candidate for mastectomy;
Istituto Oncologico Veneto IRCCS
Lead sponsor