Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

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Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.

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

IC2000 and SPY-PHI

Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer

Tc-99m radioactive colloid and Gamma Probe

David Weintritt, MD, FACS

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.

Single arm, open label, within patient study

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

Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0

Novadaq Technologies ULC, now a part of Stryker

The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.

Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised.

IC2000 and SPY-PHI: 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

Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer

IC2000/SPY-PHI

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Canada

United States

\*Please note, the region of enrollment total reflects total subjects enrolled (N=152)

Region of Enrollment

Smoker, n (%)

Alcohol consumption, n (%)

Comorbid conditions of interest, n (%)

Total enrollment (N=152)

\*PP and mITT population (N=148)

Colleen Roden, Director of Clinical Sciences and Operations

Hypothesis:

H0: QT ≤ QC - 0.05 H1: QT \> QC - 0.05

Proportion of histology confirmed lymph nodes identified using IC2000 and SPY

Proportion of histology confirmed lymph nodes identified using Tc-99m/Gamma Probe

Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe

Proportion of Subjects with At Least One Lymph Node Identified by IC2000 and SPY in-vivo

Proportion of Subjects with At Least One Lymph Node Identified by Tc-99m/Gamma Probe

PP and mITT population

\*The PP and mITT populations were identical

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

Total number of histology confirmed clinical lymph nodes (specimens) identified and excised by IC2000 and SPY.

\*The PP and mITT populations were identical

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

Spots Global Cancer Trial Database for 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

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