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NCT Number: NCT03200704

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Lymph Node Mapping Neoplasms Neoplasms by Site Sentinel Lymph Node Biopsy Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Fraser Health Authority, Port Moody, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery

Secondary outcomes

  1. 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

    Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery

  2. 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

    Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery

  3. To Assess the Safety of Intradermal Injection of IC2000

    Time frame: From Technetium-99 (Tc-99m) injection to the completion of surgery

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

Sponsors and collaborators

Lead sponsor

Novadaq Technologies ULC, now a part of Stryker

Industry

Registry information

Official study title

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

Acronym: FILM-B

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 27, 2017
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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