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

Phase 3

Completed

Interventions: Combination Product: IC2000 and SPY-PHI
Combination Product: Tc-99m radioactive colloid and Gamma Probe

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
IC2000/SPY-PHI	IC2000 and SPY-PHI	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/SPY-PHI	Tc-99m radioactive colloid and Gamma Probe	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	From Technetium-99 (Tc-99m) injection to the completion of surgery	Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0
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

Locations (7): Arizona Center for Cancer Care
🇺🇸
Scottsdale, Arizona, United States
CHU de Québec-Université Laval (Hôpital du Saint-Sacrement)
🇨🇦
Quebec City, Quebec, Canada
Inova Health System
🇺🇸
Alexandria, Virginia, United States
Baptist MD Anderson Cancer Center
🇺🇸
Jacksonville, Florida, United States
MedStar Georgetown University Hospital
🇺🇸
Washington, District of Columbia, United States
Methodist Dallas Medical Center
🇺🇸
Dallas, Texas, United States
Fraser Health Authority
🇨🇦
Port Moody, British Columbia, Canada