Upper Extremity Lymphatic Mapping for Breast Cancer Patients

Not Applicable

Completed

• Conditions: Axillary Lymph Node Dissection; Breast Cancer
• Interventions: Radiation: isosulfan blue dye

• Registration Number: NCT00717886
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-18
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2015-10
• Results First Submitted: 2015-10-19
• Results First Submitted QC: 2015-10-19
• Last Update Submitted: 2015-10-19
• Results First Posted: 2015-11-20
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	isosulfan blue dye	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.

Primary Outcome Measures

Name	Time	Method
Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).	2 years

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States