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Upper Extremity Lymphatic Mapping for Breast Cancer Patients
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, January 2009
Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00717886
  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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Iso-sulfan blue
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title: Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study

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 ]

Estimated Enrollment: 30
Study Start Date: June 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.

  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

Contacts
Contact: Leslie Montgomery, MD montgoml@mskcc.org
Contact: Dilip Giri, MD girid@mskcc.org

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Leslie Montgomery, MD         montgoml@mskcc.org    
Principal Investigator: Leslie Montgomery, MD            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Leslie Montgomery, MD Memorial Sloan-Kettering Cancer Center
  More Information

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

Responsible Party: Memorial Sloan-Kettering Cancer Center ( Leslie Montgomery M.D. )
Study ID Numbers: 08-051
Study First Received: July 16, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00717886  
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast
Lymph Nodes

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009