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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-ID-01538 | Other Identifier | UT MD Anderson Cancer Center | |
| CDR0000355838 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread.
PURPOSE: This clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer.
OBJECTIVES:
OUTLINE: At least 2 days before scheduled surgery, patients receive technetium Tc 99m sulfur colloid by peritumoral injection followed by lymphoscintigraphy. Images are obtained at 30 minutes and after 2 and 3 hours, provided no drainage is noted. Patients then receive technetium Tc 99m sulfur colloid by subareolar injection followed by another lymphoscintigraphy.
At the time of surgery, patients receive isosulfan blue by subareolar injection. A handheld gamma probe is used to locate the sentinel node. If the sentinel node is identified, it is excised and the scheduled breast surgery is performed. If the sentinel node cannot be identified, patients undergo the scheduled breast surgery.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 12.5 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection Methods | Experimental | One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosulfan Blue | Drug | At time of surgery, breast injected with 3-5 cc of isosulfan blue in subareolar or peritumoral position. |
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| Measure | Description | Time Frame |
|---|---|---|
| Lymphatic drainage patterns as determined by peritumoral and subareolar injections | Evaluate outcome descriptively. | 12 months to collect data |
| Identification rate of sentinel nodes and negative predictive value associated with subareolar injection | Evaluate outcome descriptively. | 12 months to collecte data |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gildy V. Babiera, MD | M.D. Anderson Cancer Center | Study Chair |
| Ebrahim Delpassand, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M. D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
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| Label | URL |
|---|---|
| UT MD Anderson Cancer Center Website | View source |
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| Lymphangiography | Procedure | 2 lymphoscintigraphy images performed following peritumoral and subareolar injection of breast |
|
| Technetium Tc 99m sulfur colloid | Radiation | At least 2 days before scheduled surgery, receive technetium Tc 99m sulfur colloid by peritumoral injection; and again the day before surgery by subareolar injection. At the time of surgery, patients receive isosulfan blue by subareolar injection. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C025484 | iso-sulfan blue |
| D013671 | Technetium Tc 99m Sulfur Colloid |
| ID | Term |
|---|---|
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017556 | Technetium Compounds |
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