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
Condition: Breast Cancer; Lymph Node Mapping; Sentinel Lymph Node Biopsy
MeSH terms: Breast Neoplasms
Intervention: IC2000 and SPY-PHI; Tc-99m radioactive colloid and Gamma Probe
Intervention description: Investigational treatment to assess 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 in early stage breast cancer; Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Single arm, open label, within patient study
Masking: None (Open Label)
Enrollment: 152.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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