IntraOperative UltraSound Guided vs Wire Guided vs Magnetic Seed Guided Breast-Conserving Surgery for Non-palpable Tumors

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.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* 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;
* Patients amenable for BCS after neoadjuvant chemotherapy;
* Patients who are able to give informed consent.

Exclusion Criteria:

* Pregnancy or lactation;
* Patients with locally advanced disease or metastatic disease;
* Patients with palpable breast carcinoma;
* Patients candidate for mastectomy;
* Patients who are unable to give informed consent
* Patients candidate for mastectomy.

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