SentiMag® Intraoperative Comparison in Breast Cancer

Inclusion Criteria: * Subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (DCIS). * Subjects scheduled for surgical intervention, with a sentinel lymph node biopsy procedure being a part of the surgical plan. * Subjects aged 18 years or more at the time of consent. * Subjects with an ECOG (Eastern Cooperative Oncology Group) performance status of Grade 0 - 2. * Subject has a clinical negative node status (i.e. T0-3, N0, M0). Exclusion Criteria: * The subject is pregnant or lactating. * The subject has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes. * The subject has a known hypersensitivity to Isosulfan Blue Dye. * The subject has participated in another investigational drug study within 30 days of scheduled surgery. * Subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment. * Subject has had preoperative radiation therapy to the affected breast or axilla. * Subject has received a Feraheme® (ferumoxytol) Injection within the past 6 months. * Subject has intolerance or hypersensitivity to iron or dextran compounds or to SiennaXP. * Subject has an iron overload disease. * Subject has pacemaker or other implantable device in the chest wall.