Upper Extremity Lymphatic Mapping for Breast Cancer Patients

Study Overview
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Brief Summary
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This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.

Official Title
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Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study

Conditions
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Breast Cancer, Axillary Lymph Node Dissection

Intervention / Treatment
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* Radiation: isosulfan blue dye


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND. Females > 21 years of age Exclusion Criteria: Prior ipsilateral axillary surgery Prior ipsilateral axillary radiation Prior ipsilateral breast cancer Prior ipsilateral breast radiation Allergy to isosulfan blue dye History of ipsilateral upper extremity lymphedema Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast Prior history of neoadjuvant chemotherapy for current breast cancer Bulky axillary disease at presentation (N2)

Ages Eligible for Study
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Minimum Age: 21 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients with documented axillary metastases (Stage II breast cancer) will undergo subdermal injection of technetium sulfur colloid (TSC) into the ipsilateral upper extremity approximately 3 hours before surgery. | Radiation: isosulfan blue dye<br>* At the time of surgery, each patient will undergo a subareolar injection of isosulfan blue dye into the ipsilateral breast as routinely performed during a sentinel lymph node mapping for breast cancer. The surgeon will then perform an axillary lymph node dissection in the usual, routine manner. The above differs from standard of care in that patients scheduled for an upfront axillary dissection do not routinely undergo sentinel lymph node mapping- therefore these patients would not normally get any isotope or TSC injections since they already need an ALND. Second, standard sentinel lymph node mapping involves injection of TSC into the affected breast the day prior to surgery or 3 hours before surgery versus injection of TSC into the ipsilateral upper extremity. The protocol specifies day of mapping for patient convenience.<br>* Other names: radioactive, blue only and nodes with neither will be noted.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast). |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast, Lymph Nodes