Upper Extremity Lymphatic Mapping for Breast Cancer Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Axillary Lymph Node Dissection
• Intervention / Treatment: Radiation: isosulfan blue dye

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1; 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; 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.; Other Names: Once the specimen is removed from the patient, the axillary nodes will be; dissected from the specimen and categorized: "blue only"; "radioactive only";; "blue and radioactive"; and "neither." The number of axillary nodes which are; "radioactive only" will indicate the nodes which drain the ipsilateral upper; extremity. The "blue and radioactive" nodes will indicate the sentinel lymph; nodes from the breast, which are also nodes that drain the ipstilateral upper; extremity. The prevalence of positive "radioactive only" and /or "blue and; radioactive", "blue only" and nodes with "neither" will be noted.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Leslie Montgomery, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 18, 2008

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Breast; Lymph Nodes
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 08-051