Upper Extremity Lymphatic Mapping for Breast Cancer Patients

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer; Axillary Lymph Node Dissection

Treatments: Radiation: isosulfan blue dye

Study type: Interventional

Funder types: Other

Identifiers

NCT00717886

08-051

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Radiation: isosulfan blue dye