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Axillary Reverse Mapping for Invasive Carcinoma of the Breast

NCT ID: NCT00645541

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Axillary Reverse Mapping (ARM)

Group Type EXPERIMENTAL

Axillary Reverse Mapping

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Funda Meric-Bernstam, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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UT MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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2007-0951

Identifier Type: -

Identifier Source: org_study_id