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;
Parallel
IOUS HydroMark™
Procedure/SurgeryIOUS HydroMarkTM allows marking the tissue during percutaneous breast biopsy. This is a sterile, single-use marker made of resorbable hydrogel, which expands upon contact with bodily fluids and is then gradually absorbed. The hydrogel is visible on ultrasound. Inside the hydrogel, there is a metallic spiral (titanium/steel) that remains permanently visible in radiographic and MRI examinations even after the hydrogel has been fully absorbed. The HydroMARK Breast Biopsy Site Marker is made of a resorbable hydrogel that expands with fluid and is then resorbed. The hydrogel material is visible under ultrasound. Embedded in the hydrogel is a coiled metallic wire that will be permanently visible under x-ray and MRI when the hydrogel is resorbed. The HydroMARK Biopsy Site Marker is a permanent implant and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in applicator devices designed.
Magnetic Sirius Pintuition Seed®
Procedure/SurgeryThe Pintuition Localization System is intended as a magnetic soft tissue localization system. The magnetic Pintuition Seed is indicated for preoperative percutaneous implantation into soft tissue (glandular, fibrous or fatty tissue of breast; lymph nodes in the axillary and inguinal region; subcutaneous tissue and skeletal muscle tissue) for temporary marking (\<180 days) of a tissue of interest (e.g. tumor or a suspected lesion) indicated for surgical removal. Using the Pintuition Detector as magnetic guidance or, alternatively, image guidance (ultrasound or x-ray), the Pintuition Seed can be intra-operatively localized and removed together with the tissue of interest.
Wire localization (WL)
Procedure/SurgerySingle-use, repositionable needle for preoperative localization of breast nodules with a single hook, equipped with a depth limiter. Designed for the localization of non-palpable breast lesions in the preoperative phase. It includes a fixation clamp to stabilize the positioning of the wire.
Involved resection margins.
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.
Postoperative complications
Evaluate the 3 techniques in terms of postoperative complications, assessed according to the Clavien-Dindo classification system.
Re-excision rate
Evaluate the 3 techniques in terms of re-excision rate, defined as the number of patients who need to be re-operated after initial conservative surgery out of the total number of operated patients. Reoperation was recommended for any resection margin \< 2 mm.
Target lesion removal rates
Evaluate the 3 techniques in terms of target lesion removal rates, defined as the number of lesions that were totally removed without involved margins after first surgical excision
Closest margin width
Evaluate the 3 techniques in terms of closest margin width, calculated as the minimal distance between the tumor edge and the closest resection margin
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