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Axillary Reverse Mapping for Invasive Carcinoma of the Breast

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00645541
First received: March 25, 2008
Last updated: August 1, 2012
Last verified: August 2012

March 25, 2008
August 1, 2012
March 2008
November 2010   (final data collection date for primary outcome measure)
Identification Rate for Feasibility of ARM in Patients Undergoing Axillary Lymph Node Dissection for breast cancer therapy [ Time Frame: 2 years for overall study ] [ Designated as safety issue: No ]
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.
The goal of this clinical research study is to learn if axillary reverse mapping can find lymph nodes that are draining the arm. [ Time Frame: 30 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00645541 on ClinicalTrials.gov Archive Site
Incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by ARM [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The relationship between breast cancer and any draining lymph nodes found will also be studied. [ Time Frame: 30 Months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Axillary Reverse Mapping for Invasive Carcinoma of the Breast
Axillary Reverse Mapping for Invasive Carcinoma of the Breast

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Cancer
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).
Experimental: Axillary Reverse Mapping (ARM)
Intervention: Procedure: Axillary Reverse Mapping
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00645541
2007-0951
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Funda Meric-Bernstam, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP