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Axillary Reverse Mapping for Invasive Carcinoma of the Breast


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

Axillary Reverse Mapping for Invasive Carcinoma of the Breast


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Identification Rate for Feasibility of ARM in Patients Undergoing Axillary Lymph Node Dissection for breast cancer therapy

Outcome Description:

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.

Outcome Time Frame:

2 years for overall study

Safety Issue:

No

Principal Investigator

Funda Meric-Bernstam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0951

NCT ID:

NCT00645541

Start Date:

March 2008

Completion Date:

November 2010

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Carcinoma of the Breast
  • Lymph Nodes
  • Lymphazurin
  • Axillary Reverse Mapping
  • Breast Neoplasms
  • Carcinoma

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030