Axillary Reverse Mapping for Invasive Carcinoma of the Breast

NCT00645541 | Completed Phase 1

• 1 other identifier: 2007-0951
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Carcinoma of the Breast; Lymph Nodes; Lymphazurin; Axillary Reverse Mapping

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by ARM

  2 years

Study Arms (1)

Axillary Reverse Mapping (ARM)

EXPERIMENTAL

Procedure: Axillary Reverse Mapping

Interventions

Axillary Reverse Mapping PROCEDURE

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).

Axillary Reverse Mapping (ARM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Funda Meric-Bernstam, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 27, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: August 2, 2012

Record last verified: 2012-08

Locations

US (1)