Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Single arm, open label, within patient study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IC2000/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.
  • Combination Product: 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
  • Combination Product: Tc-99m radioactive colloid and Gamma Probe
    Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer

More Details

Status
Completed
Sponsor
Novadaq Technologies ULC, now a part of Stryker

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.