Axillary Reverse Mapping

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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ARM: Axillary Reverse Mapping, A Prospective Study

Conditions
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Cancer of the Breast

Intervention / Treatment
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* Procedure: Axillary Reverse Mapping


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sentinel Lymph Node Biopsy Only<br>Axillary Reverse Mapping | Procedure: Axillary Reverse Mapping<br>* 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.<br>|
| Other: Full Axillary Lymph Node Dissection<br>Axillary Reverse Mapping | Procedure: Axillary Reverse Mapping<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of lymphedema by the first year following surgery | 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful identification (i.e., localization) of breast SLN and arm lymphatics | successful localization of one or more lymph nodes to which the peritumoral breast region drains | Time of surgery | 
| Characterization of location (typical versus variant) of arm lymphatics. | brief location details will also be collected. | Time of surgery | 
| Successful protection of the arm lymphatics during SLNB and/or ALND. | successful avoidance of resection and/or successful preservation of structural integrity of arm lymphatics during the surgical procedure. | Time of surgery | 
| Occurrence of crossover (i.e., co-localization) between hot breast SLN and blue arm lymphatics. | 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. | Time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel Lymph Node Biopsy, Axillary Node Dissection, Prevention of lymphedema, Prevention of neuroma, Prevention of seroma