CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 152 enrolled
Drug / intervention
IC2000 and SPY-PHI +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03200704
NCT03200704Phase 3Completed
CompareCT.gov

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

Novadaq Technologies ULC, now a part of Stryker·interventional·Posted Jun 27, 2017·Updated Sep 21, 2023

In Brief

A Phase 3 clinical trial evaluating IC2000 and SPY-PHI and Tc-99m radioactive colloid and Gamma Probe for Breast Cancer and 2 related conditions. Completed, enrolled 152 participants across 7 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Lymph Node Mapping, Sentinel Lymph Node Biopsy
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 27, 2017
Enrollment StartJan 4, 2019
Primary CompletionAug 27, 2020
Study CompletionSep 28, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.0 years ago

Interventions

IC2000 and SPY-PHIcombination

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 Probecombination

Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer