A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer

Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Subjects With Breast Cancer

This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures as confirmed by Technitium99m (Tc99m) and Gamma Probe.

Inclusion Criteria:

1. Be 18 years of age or older

2. Subjects with American Cancer Society Clinical Stage 0 Ductal Carcinoma in Situ (DCIS) (Stage 0, Tis, N0, M0), IA (T1*, N0, M0), IB ((T0, N1mi, M0) or T1*, N1mi, M0)) or Stage IIA (T0, N1**M0, or T1, N1**, M0 or T2, N0, M0)1 breast cancer undergoing surgery to remove tumor draining LNs.

   Where:

   • Tis = Ductal carcinoma in situ
   • T0 = No evidence of primary tumor
   • T1 = Tumor ≤ 20 mm in greatest diameter
   • T1* = Includes T1mi
   • T2 = Tumor >20 mm but ≤ 50 mm in greatest diameter
   • N0 = No regional lymph node metastasisq1'
   • N1 = Metastasis to movable ipsilateral level I, II axillary LNs
   • N1** = T0 and T1 tumors with nodal micro-metastasis only are excluded from Stage IIA and are classified Stage IB.
   • mi = Micro-metastasis
   • M0 = Disease has not metastasized from Stage IIA and are classified Stage IB.
   • M0= No evidence of metastasis
   • mi= Micrometastasis

3. Subjects with clinically negative nodal status (N0) with or without neoadjuvant chemotherapy

4. Subjects with negative metastatic involvement (M0)

5. Subjects of child-bearing potential must not be pregnant or lactating and must have a negative pregnancy test at Baseline

6. Have signed an approved informed consent form for the study

7. Be willing to comply with the protocol

Exclusion Criteria:

1. Have had prior axillary surgery or ipsilateral radiation in the breast(s) that is planned for the procedure
2. Advanced breast cancer subjects with stage IIB, III and IV
3. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
4. Subjects who have participated in another investigational study within 30 days prior to surgery
5. Pregnant or lactating subject
6. Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for