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Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer

NCT01771666 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-12-11

Study results available
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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.

Conditions

Interventions

DEVICE

SPY Elite Imaging

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

DRUG

Indocyanine Green

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

DRUG

Isosulfan blue

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

DRUG

99technetium-sulfur colloid radiolabel

Sponsors & Collaborators

Principal Investigators

  • Irene Wapnir · Stanford University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-03-17
Completion
2015-03-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01771666 on ClinicalTrials.gov