Axillary Reverse Mapping for Invasive Carcinoma of the Breast

August 1, 2012 updated by: M.D. Anderson Cancer Center

Primary Objectives:

  • To determine the feasibility of axillary reverse mapping (ARM) in patients undergoing axillary lymph node dissection for breast cancer therapy.
  • To determine the incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by axillary reverse mapping.
  • To determine the safety of axillary reverse mapping.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lymphazurin is a blue dye used usually in breast cancer surgery to trace the drainage pathway that flows to lymph nodes. The dye will travel to the lymph system and will end up in the lymph nodes that are draining the arm.

In this study, lymphazurin will be used to find the drainage routes from your arm, rather than your breast.

AXILLARY REVERSE MAPPING:

Before axillary lymph node surgery, your surgeon will inject lymphazurin into your arm. Your surgeon will watch how the dye flows and find the channels and nodes draining the arm. You will then have standard axillary lymph node (lymph nodes found under the arm) surgery. Any lymph nodes found that are dyed blue (lymph nodes that have traveled down the drainage pathways) that would normally be removed will be removed and sent to the pathology department. Pathologists will check the nodes to see if they have breast cancer cells in them. Also as part of routine care, all other axillary lymph nodes draining the breast will be removed and checked for breast cancer cells.

This is an investigational study. Lymphazurin is FDA approved and commercially available. The use of lymphazurin with axillary reverse mapping is investigational.

Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with invasive carcinoma of the breast planning to undergo axillary lymph node dissection at M. D. Anderson Cancer Center.
  • Eastern Cooperative Oncology Group (ECOG) performance status of equal to or less than 3.

Exclusion Criteria:

  • Patients with known allergies to blue dye or other contraindications to Lymphazurin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Axillary Reverse Mapping (ARM)
Procedure: Axillary Reverse Mapping
Lymphazurin, isosulfan blue dye, injected into arm then a standard axillary lymph node surgery to remove any blue dyed lymph nodes found (lymph nodes that have traveled down the drainage pathways).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification Rate for Feasibility of ARM in Patients Undergoing Axillary Lymph Node Dissection for breast cancer therapy
Time Frame: 2 years for overall study
Axillary reverse mapping (ARM) performed using 2 - 5cc of isosulfan blue, injected into the inner arm prior to skin incision for the axillary lymph node dissection. Blue channels identified during surgery and locations compared to axillary vein. Any blue nodes within the standard axillary lymph node dissection field removed then sent to pathology as a separate specimen labeled "axillary reverse mapping nodes" and evaluated with serial sectioning, and hematoxylin-eosin stain (H&E) as well as immunohistochemistry.
2 years for overall study

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by ARM
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Funda Meric-Bernstam, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

March 25, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Estimate)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-0951

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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