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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
152
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
Arizona Center for Cancer Care
Scottsdale, Arizona, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
Inova Health System
Alexandria, Virginia, United States
Fraser Health Authority
Port Moody, British Columbia, Canada
CHU de Québec-Université Laval (Hôpital du Saint-Sacrement)
Québec, Quebec, Canada
Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe
Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery
Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe
Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery
Proportion of Lymph Nodes Identified by IC2000/SPY-PHI by Following a Fluorescent Lymphatic Vessel, and the Proportion of Identified Lymph Nodes With no Lymphatic Vessels Visible by IC2000/SPY-PHI
Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery
To Assess the Safety of Intradermal Injection of IC2000
Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery
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