Phase 3
N=152
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
Breast Cancer · Lymph Node Mapping · Sentinel Lymph Node Biopsy
Bottom Line
View on ClinicalTrials.gov: NCT03200704 ↗Enrolled (actual)
152
Serious AEs
2.7%
Results posted
Sep 2023
Primary outcome: Primary: Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe — 360; 266 Lymph Nodes — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IC2000 and SPY-PHI (Combination_product); Tc-99m radioactive colloid and Gamma Probe (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe |
360; 266 | <0.0001 sig |
| SECONDARY 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 |
145; 145 | — |
| SECONDARY 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 |
357; 3 | — |
| SECONDARY To Assess the Safety of Intradermal Injection of IC2000 |
3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03200704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.