Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT00572481

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Axillary Reverse Mapping

Procedure

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.

Primary outcomes

  1. Occurrence of lymphedema by the first year following surgery

    Time frame: One year

    An occurrence will consist of an increase of 20% or more in ipsilateral arm volume over the pre-surgery volume, and be accompanied by a confirmatory diagnosis of lymphedema from the UAMS lymphedema clinic.

Secondary outcomes

  1. Successful identification (i.e., localization) of breast SLN and arm lymphatics

    Time frame: Time of surgery

    successful localization of one or more lymph nodes to which the peritumoral breast region drains

  2. Characterization of location (typical versus variant) of arm lymphatics.

    Time frame: Time of surgery

    brief location details will also be collected.

  3. Successful protection of the arm lymphatics during SLNB and/or ALND.

    Time frame: Time of surgery

    successful avoidance of resection and/or successful preservation of structural integrity of arm lymphatics during the surgical procedure.

  4. Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics.

    Time frame: Time of surgery

    A crossover event will consist of identification of one or more lymph nodes that are both focally radioactive following peritumoral Tc99m injection and noticeably stained blue following ipsilateral arm injection with Lymphazurin.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

ARM: Axillary Reverse Mapping, A Prospective Study

Acronym: ARM

Important dates

Study start
2007
Primary completion
2026
Study completion
2027
First posted
Dec 13, 2007
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.