Axillary Reverse Mapping (ARM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 30, 2014
Last verified: July 2014

December 11, 2007
July 30, 2014
May 2007
May 2015   (final data collection date for primary outcome measure)
Occurrence of lymphedema by the first year following surgery [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00572481 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Axillary Reverse Mapping
ARM: Axillary Reverse Mapping

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Cancer of the Breast
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.
No Intervention: 1
Intervention: Procedure: Axillary Reverse Mapping

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
May 2016
May 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
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
United States
 
NCT00572481
UAMS 78076
No
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: V. Suzanne Klimberg, MD University of Arkansas
University of Arkansas
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP