NCT03200704View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

January 4, 2019

Primary Completion Date

August 27, 2020

Study Completion Date

September 28, 2020

Conditions
Breast CancerLymph Node MappingSentinel Lymph Node Biopsy
Interventions
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

Trial Locations (7)

20007

MedStar Georgetown University Hospital, Washington D.C.

22306

Inova Health System, Alexandria

32207

Baptist MD Anderson Cancer Center, Jacksonville

75203

Methodist Dallas Medical Center, Dallas

85258

Arizona Center for Cancer Care, Scottsdale

V3H 3W9

Fraser Health Authority, Port Moody

G1R 2J6

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

All Listed Sponsors
lead

Novadaq Technologies ULC, now a part of Stryker

INDUSTRY

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 | Biotech Hunter | Biotech Hunter