Upper Extremity Lymphatic Mapping for Breast Cancer Patients - Full Text View

Purpose

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.

Condition	Intervention
Breast Cancer Axillary Lymph Node Dissection	Radiation: isosulfan blue dye

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Isosulfan blue

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

Number and prevalence of metastases of blue nodes in the ALND specimen (nodes draining the breast). [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
Number and prevalence of metastases of radioactive nodes in the ALND specimen (nodes draining the ipsilateral upper extremity). [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
Number and prevalence of metastases of blue and radioactive nodes in the ALND specimen (nodes draining both the breast and the ipsilateral upper extremity). [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
Number and prevalence of metastases of nodes that are neither blue nor radioactive. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Enrollment:	13
Study Start Date:	June 2008
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717886

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Leslie Montgomery, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Leslie Montgomery M.D., Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00717886 History of Changes
Other Study ID Numbers:	08-051
Study First Received:	July 16, 2008
Last Updated:	January 5, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Breast
Lymph Nodes

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013