Axillary Reverse Mapping (ARM)

ARM: Axillary Reverse Mapping, A Prospective Study

We hypothesize that variations in anatomic location of the arm lymphatic drainage system put the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping the drainage of the arm during the procedure would decrease the likelihood of inadvertent disruption of the lymphatics and the subsequent development of lymphedema. A combination of radioactivity and blue dye will be used.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer of the Breast
• Intervention / Treatment: Procedure: Axillary Reverse Mapping

Detailed Description

Mapping Procedure:

Each patient will receive an injection of 1.0 mCi of technetium-99m sulfur colloid into the normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor.

If the radioactive SLN cannot be located prior to incision via gamma probe then the blue dye will be used in the breast either in the subareolar plexus or peritumorally at the discretion of the surgeon. For this contingency (expected to occur <3% of the time), the blue dye will be used in the breast (and NOT the arm), as the prime concern is locating the SLN for staging.

If the blue dye is unnecessary to find the sentinel node draining from the breast, then it will be injected dermally in the upper inner arm along the Biceps groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in either the subareolar plexus, peritumorally (intraparenchymal or dermally), or dermally in the patient's ipsilateral arm dependent upon the contingencies stated above. Site of all injections (radioactivity and/or blue dye) will be recorded.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-100 years old
• Not pregnant or breastfeeding
• Breast cancer requiring lymph node evaluation for the ipsilateral or contralateral breast OR prophylactic mastectomy
• Willing participation following an informed consent process

Exclusion Criteria:

• Patient < 18 y/o or > 100 y/o
• Pregnant or breastfeeding
• If a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sentinel Lymph Node Biopsy Only; Axillary Reverse Mapping	Procedure: Axillary Reverse Mapping; During surgery, the technetium-99m sulfur colloid will be injected into the breast and the blue dye injected (if the patient is not allergic and it is not required to locate the SLN) in the patient's ipsilateral upper arm. The lymph node biopsy and/or dissection will be performed by the surgeon, according to standard practice.
Other: Full Axillary Lymph Node Dissection; Axillary Reverse Mapping	Procedure: Axillary Reverse Mapping; During surgery, the technetium-99m sulfur colloid will be injected into the breast and the blue dye injected (if the patient is not allergic and it is not required to locate the SLN) in the patient's ipsilateral upper arm. The lymph node biopsy and/or dissection will be performed by the surgeon, according to standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of lymphedema by the first year following surgery	An occurrence will consist of an increase of 20% or more in ipsilateral arm volume over the pre-surgery volume, and be accompanied by a confirmatory diagnosis of lymphedema from the UAMS lymphedema clinic.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful identification (i.e., localization) of breast SLN and arm lymphatics	successful localization of one or more lymph nodes to which the peritumoral breast region drains	Time of surgery
Characterization of location (typical versus variant) of arm lymphatics.	brief location details will also be collected.	Time of surgery
Successful protection of the arm lymphatics during SLNB and/or ALND.	successful avoidance of resection and/or successful preservation of structural integrity of arm lymphatics during the surgical procedure.	Time of surgery
Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics.	A crossover event will consist of identification of one or more lymph nodes that are both focally radioactive following peritumoral Tc99m injection and noticeably stained blue following ipsilateral arm injection with Lymphazurin.	Time of surgery

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Daniela Ochoa, MD, University of Arkansas

Publications and helpful links

General Publications

• Thompson M, Korourian S, Henry-Tillman R, Adkins L, Mumford S, Westbrook KC, Klimberg VS. Axillary reverse mapping (ARM): a new concept to identify and enhance lymphatic preservation. Ann Surg Oncol. 2007 Jun;14(6):1890-5. doi: 10.1245/s10434-007-9412-x. Epub 2007 May 4.
• Klimberg VS. A new concept toward the prevention of lymphedema: axillary reverse mapping. J Surg Oncol. 2008 Jun 1;97(7):563-4. doi: 10.1002/jso.20905. No abstract available.
• Boneti C, Korourian S, Bland K, Cox K, Adkins LL, Henry-Tillman RS, Klimberg VS. Axillary reverse mapping: mapping and preserving arm lymphatics may be important in preventing lymphedema during sentinel lymph node biopsy. J Am Coll Surg. 2008 May;206(5):1038-42; discussion 1042-4. doi: 10.1016/j.jamcollsurg.2007.12.022. Epub 2008 Mar 3.
• Boneti C, Korourian S, Diaz Z, Santiago C, Mumford S, Adkins L, Klimberg VS. Scientific Impact Award: Axillary reverse mapping (ARM) to identify and protect lymphatics draining the arm during axillary lymphadenectomy. Am J Surg. 2009 Oct;198(4):482-7. doi: 10.1016/j.amjsurg.2009.06.008.
• Boneti C, Badgwell B, Robertson Y, Korourian S, Adkins L, Klimberg V. Axillary reverse mapping (ARM): initial results of phase II trial in preventing lymphedema after lymphadenectomy. Minerva Ginecol. 2012 Oct;64(5):421-30.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 11, 2007
• First Submitted That Met QC Criteria: December 12, 2007
• First Posted (Estimated): December 13, 2007

Study Record Updates

• Last Update Posted (Estimated): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Sentinel Lymph Node Biopsy; Axillary Node Dissection; Prevention of lymphedema; Prevention of neuroma; Prevention of seroma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 78076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No