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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 used to visualize lymphatic vessels and identify lymph nodes during sentinel lymph node biopsy in subjects with breast cancer. The combination is being studied as an imaging approach to aid in lymph node mapping during this surgical procedure.
IC2000 and SPY-PHI are developed by Stryker Corporation, which trades under the ticker SYK. Stryker is the developer of this imaging system intended for use in sentinel lymph node biopsy procedures in breast cancer patients.
IC2000 and SPY-PHI are in Phase 3 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being studied for its safety and effectiveness in visualizing lymphatic vessels and identifying lymph nodes during sentinel lymph node biopsy.
IC2000 and SPY-PHI have one completed Phase 3 clinical trial, NCT03200704. This study assessed the safety and effectiveness of the imaging systems in visualizing lymphatic vessels and identifying lymph nodes during sentinel lymph node biopsy in subjects with breast cancer. The trial enrolled 152 female participants aged 18 years and older in the United States and Canada.
IC2000 and SPY-PHI are the names of the imaging systems being studied together. The clinical trial title refers to them as IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI). They are used in combination to visualize lymphatic vessels and identify lymph nodes during sentinel lymph node biopsy.