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.