Clinical Evaluation of LS-03M/LS-04R for the Detection of Sentinel Lymph Node Metastasis From Breast Cancer

Inclusion Criteria:

- Male or Female patients, over the age of 18, diagnosed pre-surgically with T1 or T2
breast cancer and scheduled for surgery including sentinel node dissection.

- Patients who have read and understand the informed consent form and are capable and
willing to provide written informed consent.

Exclusion Criteria:

- Patients diagnosed pre-surgically with large or locally advanced (T3 and T4) breast
cancers.

- Patients diagnosed with inflammatory breast cancer.

- Patients diagnosed with ductal carcinoma in situ (DCIS) when breast conserving is to
be done.

- Patients who are pregnant, as confirmed by a patient/treating physician interview.

- Patients with suspicious palpable axillary lymph nodes.

- Patients currently being treated for or previously diagnosed with, another type of
carcinoma.

- Patients who have undergone prior non-oncologic breast surgery or axillary surgery.

- Patients who have received pre-operative systemic therapy.

- Patients who are incapable of providing written informed consent.

- Patients who have been judged to be inappropriate by a medical care provider (i.e.
surgeon, oncologist, pathologists, etc.).