Axillary Reverse Mapping

NCT00572481 | Active Not Recruiting Phase 2

• 1 other identifier: 78076
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of the Breast

Keywords

Sentinel Lymph Node Biopsy; Axillary Node Dissection; Prevention of lymphedema; Prevention of neuroma; Prevention of seroma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Successful identification (i.e., localization) of breast SLN and arm lymphatics

  Time of surgery

• Characterization of location (typical versus variant) of arm lymphatics.

  Time of surgery

• Successful protection of the arm lymphatics during SLNB and/or ALND.

  Time of surgery

• Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics.

  Time of surgery

Study Arms (2)

Sentinel Lymph Node Biopsy Only

OTHER

Axillary Reverse Mapping

Procedure: Axillary Reverse Mapping

Full Axillary Lymph Node Dissection

OTHER

Axillary Reverse Mapping

Procedure: Axillary Reverse Mapping

Interventions

Axillary Reverse Mapping PROCEDURE

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.

Full Axillary Lymph Node Dissection; Sentinel Lymph Node Biopsy Only

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (5)

• 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.

  PMID: 17479341 BACKGROUND

• 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.

  PMID: 17955452 BACKGROUND

• 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.

  PMID: 18471751 RESULT

• 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.

  PMID: 19800452 RESULT

• 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.

  PMID: 23018481 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniela Ochoa, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 13, 2007
• Study Start: May 1, 2007
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)