Axillary Reverse Mapping (ARM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00572481
First received: December 11, 2007
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Cancer of the Breast
Procedure: Axillary Reverse Mapping
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Occurrence of lymphedema by the first year following surgery [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Successful identification (i.e., localization) of breast SLN and arm lymphatics [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
  • Characterization of location (typical versus variant) of arm lymphatics. [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
  • Successful protection of the arm lymphatics during SLNB and/or ALND. [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
  • Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics. [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: May 2007
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1 Procedure: Axillary Reverse Mapping
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.

Detailed Description:

Mapping Procedure:

Each patient will receive an injection of 1.0 mCi of technetium-99m sulfur colloid into the normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor.

If the radioactive SLN cannot be located prior to incision via gamma probe then the blue dye will be used in the breast either in the subareolar plexus or peritumorally at the discretion of the surgeon. For this contingency (expected to occur <3% of the time), the blue dye will be used in the breast (and NOT the arm), as the prime concern is locating the SLN for staging.

If the blue dye is unnecessary to find the sentinel node draining from the breast, then it will be injected dermally in the upper inner arm along the Biceps 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 either the subareolar plexus, peritumorally (intraparenchymal or dermally), or dermally in the patient's ipsilateral arm dependent upon the contingencies stated above. 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:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-100 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

Exclusion Criteria:

  • 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.
  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: NCT00572481

Contacts
Contact: Laura L Adkins, MAP, CCRP 501-526-6990 ext 8268 lladkins@uams.edu
Contact: Maureen McCarthy, RNP 501-526-6990 ext 8265 mamccarthy@uams.edu

Locations
United States, Arkansas
University of Arkansas For Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Principal Investigator: V. Suzanne Klimberg, MD         
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: V. Suzanne Klimberg, MD University of Arkansas
  More Information

Publications:
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00572481     History of Changes
Other Study ID Numbers: UAMS 78076
Study First Received: December 11, 2007
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Sentinel Lymph Node Biopsy
Axillary Node Dissection
Prevention of lymphedema
Prevention of neuroma
Prevention of seroma

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

ClinicalTrials.gov processed this record on July 23, 2014