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
  Purpose

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.

Condition Intervention Phase
Breast Cancer
Procedure: Axillary Reverse Mapping
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Axillary Reverse Mapping for Invasive Carcinoma of the Breast

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 35
Study Start Date: March 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645541

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Funda Meric-Bernstam, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00645541     History of Changes
Other Study ID Numbers: 2007-0951
Study First Received: March 25, 2008
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Carcinoma of the Breast
Lymph Nodes
Lymphazurin
Axillary Reverse Mapping

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 22, 2014