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IC2000 and SPY-PHI · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| IC2000/SPY-PHI | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| IC2000 and SPY-PHI | COMBINATION_PRODUCT | 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 | COMBINATION_PRODUCT | Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer |
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 ...
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IC2000 and SPY-PHI are fluorescence imaging systems developed by Stryker Corporation for use during surgery. They are used to visualize lymphatic vessels and identify lymph nodes during sentinel lymph node biopsy in patients with breast cancer. The technology is a small molecule imaging approach studied in a Phase 3 clinical trial.
IC2000 and SPY-PHI are used to visualize lymphatic vessels and identify lymph nodes during sentinel lymph node biopsy in subjects with breast cancer. The imaging systems are intended to assist surgeons in locating and mapping lymph nodes as part of the biopsy procedure in female patients aged 18 years and older.
IC2000 and SPY-PHI are developed by Stryker Corporation, which trades under the ticker SYK. Stryker is the sponsor of the clinical study evaluating these fluorescence imaging systems in breast cancer patients undergoing sentinel lymph node biopsy.
IC2000 and SPY-PHI have been evaluated in a Phase 3 clinical trial, which is now completed. The study was an uncontrolled, non-randomized trial that enrolled 152 female participants aged 18 years and older in the United States and Canada.
IC2000 and SPY-PHI were studied in clinical trial NCT03200704, titled 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. The Phase 3 trial is completed and enrolled 152 participants.