Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer

Inclusion Criteria:

Female gender
Age > 18 years
Histologic diagnosis of invasive breast cancer or DCIS
The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation
The tumor is unifocal; possible satellite lesions < or = 2 cm from primary are eligible
The tumor enhances on prone breast MRI imaging
The tumor is ≥ 1 cm in diameter on mammography or prone MRI
Subject and surgeon agree to perform BCS
Ability to voluntarily provide informed consent

Exclusion Criteria:

Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes
Severe claustrophobia
Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy
Compromised renal function including chronic, severe kidney disease (GFR < 30 ml/min/1.73m2), or acute kidney injury
Pregnancy - In women of childbearing age a urine pregnancy test will be performed
Subjects who have received or plan to receive neoadjuvant chemotherapy
Sternal notch to nipple distance of > 32 cm as measured in a sitting or standing position
Measurement of widest circumference around breasts and arms > 135 cm
Subjects with known allergy to materials present in the device
Use of localization with devices other than a localization wire, including intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices (MarginProbe)
Subject would require > 2 localization wires, if randomized to standard of care
Multicentric tumors (additional tumors > 2 cm from primary)