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 (FILM-B)

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

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 Overview

• Status: Completed
• Conditions: Breast Cancer; Sentinel Lymph Node Biopsy; Lymph Node Mapping
• Intervention / Treatment: Combination product: IC2000 and SPY-PHI; Combination product: Tc-99m radioactive colloid and Gamma Probe

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Port Moody, British Columbia, Canada, V3H 3W9
      • Fraser Health Authority
  • Quebec
    • Quebec City, Quebec, Canada, G1R 2J6
      • CHU de Québec-Université Laval (Hôpital du Saint-Sacrement)
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Arizona Center for Cancer Care
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist MD Anderson Cancer Center
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center
  • Virginia
    • Alexandria, Virginia, United States, 22306
      • Inova Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe	From Technetium-99 (Tc-99m) injection to the completion of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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		From Technetium-99 (Tc-99m) injection to the completion of surgery
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		From Technetium-99 (Tc-99m) injection to the completion of surgery
To Assess the Safety of Intradermal Injection of IC2000	Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0	From Technetium-99 (Tc-99m) injection to the completion of surgery

Collaborators and Investigators

• Sponsor: Novadaq Technologies ULC, now a part of Stryker
• Investigators: Principal Investigator: David Weintritt, MD, FACS, National Breast Center

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Actual): August 27, 2020
• Study Completion (Actual): September 28, 2020

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SPY LNM 01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes