Upper Extremity Lymphatic Mapping for Breast Cancer Patients

NCT ID: NCT00717886

Last Updated: 2015-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-10-31

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.

Conditions

Breast Cancer; Axillary Lymph Node Dissection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

isosulfan blue dye

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Other Intervention 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.

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Montgomery, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

08-051

Identifier Type: -

Identifier Source: org_study_id