Trial | NCT03200704  Report issue

Title

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
Single Arm, Prospective, Open Label, Multicenter Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems in the Visualization of Lymphatic Vessels and Lymph Nodes During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Subjects With Breast Cancer

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Intervention/Treatment

    IC2000 and SPY-PHI ...

  • Study Participants

    152
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.
Study Started
Jan 04
2019
Primary Completion
Aug 27
2020
Study Completion
Sep 28
2020
Results Posted
Sep 21
2023
Last Update
Sep 21
2023

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

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.

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

Summary

IC2000/SPY-PHI

All Events

Event Type Organ System Event Term IC2000/SPY-PHI

Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe

IC2000/SPY-PHI

Proportion of histology confirmed lymph nodes identified using IC2000 and SPY

Proportion of histology confirmed lymph nodes identified using Tc-99m/Gamma Probe

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

IC2000/SPY-PHI

Proportion of Subjects with At Least One Lymph Node Identified by IC2000 and SPY in-vivo

Proportion of Subjects with At Least One Lymph Node Identified by Tc-99m/Gamma Probe

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

IC2000/SPY-PHI

To Assess the Safety of Intradermal Injection of IC2000

Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0

IC2000/SPY-PHI

Age, Continuous

60.2
years (Mean)
Standard Deviation: 11.50

Alcohol consumption, n (%)

Comorbid conditions of interest, n (%)

Race/Ethnicity, Customized

Region of Enrollment

Sex: Female, Male

Smoker, n (%)

Overall Study

IC2000/SPY-PHI

Drop/Withdrawal Reasons

IC2000/SPY-PHI