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Upper Extremity Lymphatic Mapping for Breast Cancer Patients

Primary Purpose

Breast Cancer, Axillary Lymph Node Dissection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
isosulfan blue dye
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast, Lymph Nodes

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).

Secondary Outcome Measures

Full Information

First Posted
July 16, 2008
Last Updated
October 19, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00717886
Brief Title
Upper Extremity Lymphatic Mapping for Breast Cancer Patients
Official Title
Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Axillary Lymph Node Dissection
Keywords
Breast, Lymph Nodes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
isosulfan blue dye
Other Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Montgomery, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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Upper Extremity Lymphatic Mapping for Breast Cancer Patients

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