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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer, Lymph Node Mapping, Sentinel Lymph Node Biopsy

Intervention / Treatment
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* Combination Product: IC2000 and SPY-PHI
* Combination Product: Tc-99m radioactive colloid and Gamma Probe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 18 years of age or older 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 Subjects with clinically negative nodal status (N0) with or without neoadjuvant chemotherapy Subjects with negative metastatic involvement (M0) Subjects of child-bearing potential must not be pregnant or lactating and must have a negative pregnancy test at Baseline Have signed an approved informed consent form for the study Be willing to comply with the protocol Exclusion Criteria: Have had prior axillary surgery or ipsilateral radiation in the breast(s) that is planned for the procedure Advanced breast cancer subjects with stage IIB, III and IV Known allergy or history of adverse reaction to ICG, iodine or iodine dyes Subjects who have participated in another investigational study within 30 days prior to surgery Pregnant or lactating subject Subjects who, in the Investigator's opinion, have any medical condition that makes the subject a poor candidate for

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm, open label, within patient study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IC2000/SPY-PHI<br>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. | Combination Product: IC2000 and SPY-PHI<br>* 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<br>Combination Product: Tc-99m radioactive colloid and Gamma Probe<br>* Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe |  | From Technetium-99 (Tc-99m) injection to the completion of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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 |  | 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 | From Technetium-99 (Tc-99m) injection to the completion of surgery |