Axillary Reverse Mapping

Breast Cancer Clinical Trial

Official title:

ARM: Axillary Reverse Mapping

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381315
• Other study ID #: 11737
• Status: Completed
• Phase: Phase 2
• First received: June 9, 2011
• Last updated: January 6, 2017
• Start date: September 2009
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Identification of breast sentinal lymph node and arm lymphatics	Successful identification (localization) of breast sentinel lymph node and arm lymphatics	at time of surgery	No
Secondary	Characterization of location	Characterization of location (typical versus variant) of arm lymphatics	at time of surgery	No
Secondary	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	No
Secondary	Occurrence of crossover	Occurrence of crossover (i.e., co-localization) between hot breast sentinel lymph node and blue arm lymphatics	at time of surgery	No