NCT01381315

Axillary Reverse Mapping

ARM: Axillary Reverse Mapping

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2011-06-27
• Last updated: 2017-01-10

Locations

1 site across 1 country: United States