Axillary Reverse Mapping

ARM: Axillary Reverse Mapping

It has been hypothesized that the proximity of the anatomic locations of the arm lymphatic drainage system to the breast lymphatic system in the axilla put the arm lymphatics at risk for disruption during a sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND). Therefore, mapping the drainage of the arm in addition to the drainage of the breast during the procedure would potentially decrease the incidence of arm lymphatic disruption and subsequent development of lymphedema while providing adequate axillary breast nodes needed for staging.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Injection of isotope; Procedure: Axillary lymph node dissection

Detailed Description

Patients will receive an injection of 1.0 mCi of technetium-99m sulfur colloid that will be injected into the sub-dermal subareolar aspect of the affected breast.

On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur < 3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital 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 any of the above mentioned scenarios. The site of all injections (radioactivity and/or blue dye) will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 18 - 100 years old
• Not pregnant or breastfeeding
• Diagnosis of breast cancer requiring LN evaluation for ipsilateral or contralateral breast or prophylactic mastectomy
• Willing participation after obtaining informed consent

Exclusion Criteria:

• < 18 or > 100 years of age
• Pregnant or breastfeeding
• Blue dye allergy
• Cosmetic allergy
• History of primary lymphedema
• Prior breast augmentation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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; During surgery, 1.0 mCi of technetium-99m sulfur colloid will be injected into sub-dermal subareolar aspect of the affected breast. The KUMC Nuclear Medicine Department will be responsible for performing the injection of the isotope and dilution of the isotope using saline to a final volume of 4.0 ml or less.	Procedure: Injection of isotope; On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur <3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital 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 any of the above mentioned scenarios.
Other: Axillary lymph node biopsy	Procedure: Axillary lymph node dissection; The one-year lymphedema rate among subjects undergoing axillary lymph node dissection with or without sentinel lymph node biopsy is ≥ 0.13. With our sample size of 58 subjects undergoing ALND, we will reject that hypothesis in favor of the alternative-that the lymphedema rate is <0.13 for subjects undergoing ALND-if lymphedema is confirmed in three or fewer (ie, 0, 1, 2, or 3) subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess lymphedema rates	The primary objective of this study is to assess and test the lymphedema rates six times at the following intervals: Pre-surgery - baseline, at 6 months, and yearly for 4 years. Since the historical control rates are different (5% for SLNB only and 13% for ALND with or without SLNB) two tests will be performed.	Four Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of breast sentinal lymph node and arm lymphatics	Successful identification (localization) of breast sentinel lymph node and arm lymphatics	at time of surgery
Characterization of location	Characterization of location (typical versus variant) of arm lymphatics	at time of surgery
Protection of the arm	Successful protection of the arm lymphatics during sentinel lymph node biopsy and/or axillary lymph node dissection	at time of surgery
Occurrence of crossover	Occurrence of crossover (i.e., co-localization) between hot breast sentinel lymph node and blue arm lymphatics	at time of surgery

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Jamie Wagner, DO, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 24, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 6, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Sentinel lymph node biopsy; Axillary lymph node dissection; Prevention of lymphedema
• Other Study ID Numbers: 11737