Breast Lymph Node Mapping

Study Overview
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Brief Summary
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The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. The information obtained in this study may provide us with better surgical techniques to identify and protect the arm lymphatic drainage system in the axilla.

Detailed Description
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This study is a non-randomized Phase II study of the Axillary Reverse Mapping (ARM) procedure for patients presenting with breast cancer requiring lymph node evaluation. The study will enroll 100 subjects, and will have two study arms: one for patients requiring only the SLNB procedure (roughly 67% of enrollees), and one for patients requiring a full ALND (roughly 33% of enrollees). For the analysis of study efficacy, each arm will be compared to its procedure-appropriate historical control for evidence of decrease in the 1-year lymphedema rate among patients undergoing SLNB or ALND. Additional data will be collected on the treatment population's (a) variability in location of arm lymphatics, and (b) incidence of SLN crossover with arm lymphatics, along with success-rate data for identifying SLNs and arm lymphatics during SLNB and/or ALND. This additional data will add to our level of knowledge and experience regarding lymph node surgery.

Official Title
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Axillary Reverse Mapping in Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Isosulfan Blue (Patent Blue Dye V)
* Other: Isosulfan Blue (Patent Blue Dye V)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19-100 years old Not pregnant or breastfeeding Breast cancer requiring LN evaluation for the breast Willing participation following an informed consent process Exclusion Criteria: Patient < 19 y/o or > 100 y/o Pregnant or breastfeeding Allergy to blue dye Locally advanced axillary disease History of receiving neoadjuvant chemotherapy treatment Prior axillary surgery or radiation therapy

Ages Eligible for Study
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Minimum Age: 19 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

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol. | Other: Isosulfan Blue (Patent Blue Dye V)<br>* Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe Pre-incision: SLN is identified Inject blue dye into patient's arm Complete procedure (SLNB and/or ALND)<br>|
| Active Comparator: 2<br>Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol. | Other: Isosulfan Blue (Patent Blue Dye V)<br>* Inject radioactive isotope and scan for sentinel node (SLN) using gamma probe Pre-incision: SLN is not identified (No localization) Inject blue dye into breast (nothing in arm) i. No localization: Inject blue dye into arm and perform ALND ii. Localization: Complete procedure (SLNB and/or ALND)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Map arm lymphatic drainage system in the axilla |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease the occurrence of lymphedema |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), lymphatics, blue dye