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

Conditions de participation

• Sexe:

  FEMALE

• Âges admissibles:

  18 and up

Critères de participation

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 or multifocal with satellite lesions \< or = 2 cm from primary tumor
* The tumor enhances on prone breast MRI imaging
* The tumor is ≥ 1 cm in diameter on prone breast MRI
* Subject and surgeon agree to perform BCS
* Subject voluntarily provides 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 that precludes prone or supine MRI
* 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 potential, 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 for sites using 60cm bore scanners, and measurement of widest circumference around breasts and arms \>145 cm for sites using 70 cm bore scanners
* 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
* Subjects with multicentric tumors (additional tumors \> 2 cm from primary)
* Subject would require chest wall muscle nerve block as part of the operation