Axillary Reverse Mapping (ARM) Technique

Study Overview
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Brief Summary
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The purpose of this pilot study is to compare a new surgical technique (axillary reverse mapping) to standard axillary surgery in patients diagnosed with invasive or in situ breast cancer.

Detailed Description
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Lymphedema is a major chronic morbidity that occurs in patients undergoing treatment for breast cancer (BC). Surgery for BC includes axillary surgery with either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Lymphedema occurs due to removal or disruption of lymphatic drainage of the arm that overlaps with drainage of the breast. The risk of lymphedema increases significantly with adjuvant radiation. Axillary reverse mapping (ARM) is a technique where blue dye is injected into the upper arm at surgery, allowing direct visualization of arm lymphatics and nodes during either SLNB or ALND. This allows preservation of arm lymphatics unless there is suspicion of metastatic disease in ARM lymphatics or if the ARM node is/are also the sentinel lymph node. Studies to date have largely been observational cohort studies, and mainly with low risk patients undergoing SLNB only. There is only one published randomized controlled trial, and this included only patients undergoing modified radical mastectomy.Our proposal is a prospective randomized pilot study. The study population includes patients undergoing axillary surgery (SLNB with mastectomy or ALND with either BCS or mastectomy or completion ALND after positive SLNB). The intervention group will undergo ARM; the control will undergo standard surgical treatment. Both groups will undergo standardized baseline and postoperative arm measurements and patients will complete symptom and quality of life questionnaires. The purpose is to determine the feasibility of the ARM technique, its accuracy in identifying and sparing arm lymphatics, and its ability to reduce the risk of lymphedema.

Official Title
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A Pilot Randomized Controlled Trial Comparing the Axillary Reverse Mapping (ARM) Technique to Standard Axillary Surgery in Breast Cancer Patients.

Conditions
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Invasive Breast Cancer, Ductal Carcinoma in Situ of the Breast

Intervention / Treatment
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* Procedure: axillary reverse mapping (ARM)
* Procedure: Standard axillary surgery (SLNB or ALND)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women diagnosed with invasive breast cancer or ductal carcinoma in situ receiving the following treatment: mastectomy and sentinel lymph node biopsy breast conserving surgery or mastectomy and axillary lymph node dissection completion axillary lymph node dissection after positive sentinel lymph node biopsy cases receiving neo-adjuvant therapy (chemotherapy or hormonal therapy) who are having axillary lymph node dissection as part of their surgical treatment - Exclusion Criteria: males with breast cancer women less than 18 years of age known allergic reaction to patent blue dye pregnant previous radiation therapy to affected side clinical N2/N3 disease -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: axillary reverse mapping<br>Axillary reverse mapping and sentinel lymph node biopsy (ARM/SLNB) or Axillary reverse mapping and axillary lymph node dissection (ARM/ALND) | Procedure: axillary reverse mapping (ARM)<br>* ARM/SLNB: patient will be injected with technetium-99 radiolabelled colloid (Tc-99) into the subareolar area of breast, then 1-2 mls of blue dye (patent blue dye) injected subcutaneously into the medial ipsilateral arm, just proximal to the medial epicondyle of the elbow, at the start of the surgical procedure. the SLN(s) will be identified (hot node) and removed, and any blue lymph nodes and lymphatics will be preserved intact, and only removed or disrupted if there is 'crossover (i.e. the blue node is also the SLN) or if clinically suspicious for metastatic disease. ARM/ALND: 1-2 mls of blue dye will be injected subcutaneously into the medial ipsilateral arm at the start of the surgical procedure. Surgeons will perform a standard level I and II axillary dissection and any blue lymph nodes or lymphatics will be preserved intact, and only removed or disrupted if blue nodes are suspicious for metastatic disease.<br>|
| Active Comparator: standard axillary surgery<br>The control group will have standard sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected). | Procedure: Standard axillary surgery (SLNB or ALND)<br>* The control group will have standard SLNB or ALND surgery without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lymphedema | Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema | Change from baseline to 6 months post-operative | 
| Lymphedema | Arm circumference measurements of both arms. An arm volume difference of > 10% will be considered clinically significant lymphedema | Change from baseline to 12 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC-QLQ-C30 | General quality of life | Change from baseline to 6 months post-operative | 
| EORTC-QLQ-C30 | General quality of life | Change from baseline to 12 months post-operative | 
| Disabilities of the Arm and Shoulder and Hand (DASH) | arm symptoms and disabilities | Change from baseline to 6 months post-operative | 
| Disabilities of the Arm and Shoulder and Hand (DASH) | arm symptoms and disabilities | Change from baseline to 12 months post-operative | 
| Post-operative complications | infection, hematoma, problems with wound healing | 30 days post-op | 
| Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1 | arm symptoms and pain | Change from baseline to 6 months post-operative | 
| Breast Cancer and Lymphedema Symptom Experience Index (BCLE-SEI) Part 1 | arm symptoms and pain | Change from baseline to 12 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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axillary reverse mapping (ARM), sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), lymphedema, breast cancer, surgery