Axillary Reverse Mapping for Invasive Carcinoma of the Breast

Tracking Information
First Submitted Date ICMJE	March 25, 2008
First Posted Date ICMJE	March 27, 2008
Last Update Posted Date	August 2, 2012
Study Start Date ICMJE	March 2008
Actual Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 3, 2011)	Identification Rate for Feasibility of ARM in Patients Undergoing Axillary Lymph Node Dissection for breast cancer therapy [ Time Frame: 2 years for overall study ]; 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.
Original Primary Outcome Measures ICMJE; (submitted: March 25, 2008)	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 ]
Change History	Complete list of historical versions of study NCT00645541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 3, 2011)	Incidence of breast cancer metastasis in lymph nodes draining in the arm as identified by ARM [ Time Frame: 2 years ]
Original Secondary Outcome Measures ICMJE; (submitted: March 25, 2008)	The relationship between breast cancer and any draining lymph nodes found will also be studied. [ Time Frame: 30 Months ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Axillary Reverse Mapping for Invasive Carcinoma of the Breast
Official Title ICMJE	Axillary Reverse Mapping for Invasive Carcinoma of the Breast
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.
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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Breast Cancer
Intervention ICMJE	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).
Study Arms	Experimental: Axillary Reverse Mapping (ARM); Intervention: Procedure: Axillary Reverse Mapping
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 3, 2011)	35
Original Estimated Enrollment ICMJE; (submitted: March 25, 2008)	30
Actual Study Completion Date	November 2010
Actual Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00645541
Other Study ID Numbers ICMJE	2007-0951
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	M.D. Anderson Cancer Center
Study Sponsor ICMJE	M.D. Anderson Cancer Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Funda Meric-Bernstam, MD M.D. Anderson Cancer Center
PRS Account	M.D. Anderson Cancer Center
Verification Date	August 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP