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

NCT03200704 | Completed Phase 3 Results DMC FDA Drug FDA Device

• 1 other identifier: SPY LNM 01
• Study Type: interventional
• Target: 152
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Breast Cancer; Lymph Node Mapping; Sentinel Lymph Node Biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

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

Study Arms (1)

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.

Combination Product: IC2000 and SPY-PHI; Combination Product: Tc-99m radioactive colloid and Gamma Probe

Interventions

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

IC2000/SPY-PHI

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

IC2000/SPY-PHI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novadaq Technologies ULC, now a part of Stryker: lead

Study Sites (7)

Arizona Center for Cancer Care

Scottsdale, Arizona, 85258, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Inova Health System

Alexandria, Virginia, 22306, United States

Location

Fraser Health Authority

Port Moody, British Columbia, V3H 3W9, Canada

Location

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

Québec, Quebec, G1R 2J6, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Colleen Roden, Director of Clinical Sciences and Operations
• Organization: Novadaq Technologies ULC, now a part of Stryker

colleen.roden@stryker.com

931-267-2041

Study Officials

• David Weintritt, MD, FACS

  National Breast Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, open label, within patient study

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 27, 2017
• Study Start: January 4, 2019
• Primary Completion: August 27, 2020
• Study Completion: September 28, 2020
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-08

Locations

CA (2); US (5)