CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Indocyanine Green +3 moredrug
Likely dose
Indocyanine Green 1mgfrom 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/NCT01771666
NCT01771666Phase 2Completed
CompareCT.gov

A Pilot Study to Assess the Utility of Indocyanine Green™ (IC-GREEN™) SPY Imaging in the Mapping of Arm Draining Lymphatics and Nodes During Sentinel Node Resection With or Without Axillary Dissection in Breast Cancer

Stanford University·interventional·Posted Jan 18, 2013·Updated Dec 11, 2017

In Brief

A Phase 2 clinical trial evaluating SPY Elite Imaging, Indocyanine Green, and 2 other interventions for Breast Cancer. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 18, 2013
Enrollment StartJul 1, 2012
Primary CompletionMar 17, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.5 years ago

Interventions

SPY Elite Imagingdevice

A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes

Indocyanine Greendrug

started at 1mg /mL If fluorescence is not detected with this dose, then it will be increased by 50%.

Isosulfan bluedrug

3 to 5 mL If fluorescence is not detected with this dose, then it will be increased by 50%.

99technetium-sulfur colloid radiolabeldrug