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

Last updated: August 30, 2023
Sponsor: Novadaq Technologies ULC, now a part of Stryker
Overall Status: Completed

Phase

3

Condition

Breast Cancer

Cancer

Treatment

IC2000 and SPY-PHI

Tc-99m radioactive colloid and Gamma Probe

Clinical Study ID

NCT03200704
SPY LNM 01
  • Ages > 18
  • Female

Study 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

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)) orStage IIA (T0, N1M0, or T1, N1, M0 or T2, N0, M0)1 breast cancer undergoingsurgery 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 StageIIA 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
  1. Subjects with clinically negative nodal status (N0) with or without neoadjuvantchemotherapy
  2. Subjects with negative metastatic involvement (M0)
  3. Subjects of child-bearing potential must not be pregnant or lactating and must have anegative pregnancy test at Baseline
  4. Have signed an approved informed consent form for the study
  5. Be willing to comply with the protocol

Exclusion

Exclusion Criteria:

  1. Have had prior axillary surgery or ipsilateral radiation in the breast(s) that isplanned 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 priorto surgery
  5. Pregnant or lactating subject
  6. Subjects who, in the Investigator's opinion, have any medical condition that makes thesubject a poor candidate for

Study Design

Total Participants: 152
Treatment Group(s): 2
Primary Treatment: IC2000 and SPY-PHI
Phase: 3
Study Start date:
January 04, 2019
Estimated Completion Date:
September 28, 2020

Connect with a study center

  • Fraser Health Authority

    Port Moody, British Columbia V3H 3W9
    Canada

    Site Not Available

  • CHU de Québec-Université Laval (Hôpital du Saint-Sacrement)

    Quebec City, Quebec G1R 2J6
    Canada

    Site Not Available

  • Arizona Center for Cancer Care

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Methodist Dallas Medical Center

    Dallas, Texas 75203
    United States

    Site Not Available

  • Inova Health System

    Alexandria, Virginia 22306
    United States

    Site Not Available

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