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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isosulfan blue dye | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast). | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Montgomery, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Upper Extremity Lymphatic Mapping for Breast Cancer Patients | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Upper Extremity Lymphatic Mapping for Breast Cancer Patients | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast). | Posted | Number | participants | 2 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Upper Extremity Lymphatic Mapping for Breast Cancer Patients | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leslie Montgomery | Memorial Sloan Kettering Cancer Center | (212) 639-5386 | Montgoml@mskcc.org |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C027982 | RID |
| D011851 | Radioactivity |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
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| 0 |
| 9 |
| 0 |
| 9 |
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| D017437 |
| Skin and Connective Tissue Diseases |