Axillary Reverse Mapping

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01381315
First received: June 9, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: Injection of isotope
Procedure: Axillary lymph node dissection
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ARM: Axillary Reverse Mapping

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Assess lymphedema rates [ Time Frame: Four Years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Identification of breast sentinal lymph node and arm lymphatics [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]
    Successful identification (localization) of breast sentinel lymph node and arm lymphatics

  • Characterization of location [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]
    Characterization of location (typical versus variant) of arm lymphatics

  • Protection of the arm [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]
    Successful protection of the arm lymphatics during sentinel lymph node biopsy and/or axillary lymph node dissection

  • Occurrence of crossover [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]
    Occurrence of crossover (i.e., co-localization) between hot breast sentinel lymph node and blue arm lymphatics


Estimated Enrollment: 211
Study Start Date: September 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01381315

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Carol Connor, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01381315     History of Changes
Other Study ID Numbers: 11737
Study First Received: June 9, 2011
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Sentinel lymph node biopsy
Axillary lymph node dissection
Prevention of lymphedema

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2014