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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT03200704•Novadaq Technologies ULC, now a part of Stryker

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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
+10 more criteria

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

Locations (7)

Arizona Center for Cancer Care

Scottsdale, Arizona, United States

MedStar Georgetown University Hospital

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

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Methodist Dallas Medical Center

Dallas, Texas, United States

Inova Health System

Alexandria, Virginia, United States

Fraser Health Authority

Port Moody, British Columbia, Canada

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

Québec, Quebec, Canada

Key Dates

Start Date

January 4, 2019

Primary Completion Date

August 27, 2020

Completion Date

September 28, 2020

Last Updated

September 21, 2023

Enrollment

152

ACTUAL participants

Conditions

Breast CancerLymph Node MappingSentinel Lymph Node Biopsy

Interventions

IC2000 and SPY-PHI

COMBINATION_PRODUCT

Tc-99m radioactive colloid and Gamma Probe

COMBINATION_PRODUCT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer