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Fluorescent Dyes for Lymph Node Mapping

NCT01095913 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-01-08

No results posted yet for this study

Summary

The goal of this clinical research study is to find lymph nodes before surgery using a dye called indocyanine green (IC-Green).

Objectives:

1. To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to identify all axillary lymph nodes.
2. To determine the feasibility of using nonradioactive optical imaging techniques with ICG as a fluorescent contrast agent to characterize lymphatic architecture and function in women with breast cancer who are scheduled for axillary node dissection.

Conditions

Interventions

DRUG

Indocyanine green (ICG)

Injections performed after induction of anesthesia for surgery; 25 µg ICG/injection, with injections of 0.1 cc each to be made starting in the hand, arm, and areolar regions of the breast.

Sponsors & Collaborators

  • American Cancer Society, Inc.

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Funda Meric-Bernstam, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01095913 on ClinicalTrials.gov