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| ID | Type | Description | Link |
|---|---|---|---|
| SCCC-2003161 | Other Identifier | University of Miami Sylvester Comprehensive Cancer Center | |
| WIRB-20050911 | Other Identifier | Western Institutional Review Board |
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RATIONALE: Diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. It may also help doctors plan the best treatment.
PURPOSE: This clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage I or stage II breast cancer.
OBJECTIVES:
OUTLINE: Patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). Patients receive a radioactive tracer (i.e., technetium Tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (IMSLN). Identified axillary sentinel lymph nodes are dissected. Identified IMSLNs are removed through the lumpectomy/mastectomy incision, if accessible. If they are not accessible, patients undergo thorascopic IMSLN biopsy to remove the nodes.
All removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel Lymph Node Biopsy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isosulfan blue | Drug | Administered pre-surgery; injection of 2 cc of Isosulfan Blue in four equal aliquots of 0.5 cc as routinely done for the axillary sentinel node procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy | 5 years | |
| Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes | 5 years | |
| Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes | 5 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Stage I or II disease (T1-T2, N0, M0/MX disease)
Medially or centrally located lesion
No multicentric disease
No clinically positive axillary nodes
No enlarged internal mammary nodes by CT scan
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior thoracic or cardiac surgery
No prior ipsilateral chest tube placement
No prior neoadjuvant chemotherapy
No prior radiotherapy to the mediastinum
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| Name | Affiliation | Role |
|---|---|---|
| Eli Avisar, MD | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18723148 | Result | Avisar E, Molina MA, Scarlata M, Moffat FL. Internal mammary sentinel node biopsy for breast cancer. Am J Surg. 2008 Oct;196(4):490-4. doi: 10.1016/j.amjsurg.2008.06.003. Epub 2008 Aug 23. |
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Between 2001 and 2007 a prospective database was obtained of all patients undergoing internal mammary sentinel lymph node biopsies using an open or thoracoscopic approach. Radiotracer injection was peritumoral.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sentinel Lymph Node Biopsy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Axillary Lymph Node Dissection | Procedure | Axillary Lymph Node Dissection |
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| Surgery | Procedure | The surgery will be performed under general anesthesia with a single lumen endo-tracheal tube. The patient will be laid in a semi decubitus position on the opposite side with the ipsilateral arm bent over the head and attached to an arm rest. |
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| Sentinel Lymph Node Biopsy | Procedure | Sentinel Lymph Node Biopsy |
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| Thoracoscopic Surgery | Procedure | Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy. |
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| Technetium Tc 99m Sulfur Colloid | Radiation | Two to three hours prior to surgery, a peritumoral injection of filtered Technetium Sulfur Colloid will be performed in four 0.25 mci/2cc aliquots |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm |
| 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 | Participants |
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| Age, Continuous | Median | Full Range | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy | Posted | Number | participants | 5 years |
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| Primary | Rate of Metastatic Disease in Internal Mammary Sentinel Lymph Nodes | Posted | Number | participants | 5 years |
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| Primary | Number of Patients With Identifiable Internal Mammary Sentinel Lymph Nodes | Of the 39 patients enrolled, 34 had identifiable internal mammary sentinel lymph nodes. | Posted | Number | participants | 5 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 | Single Arm | 0 | 34 | 0 | 34 |
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A total of 39 subjects were enrolled however; only 34 of the subjects had identifiable internal mammary sentinel lymph nodes. As a result, the data of 34 subjects were analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eli Avisar MD | UM/Sylvester Comprehensive Cancer Center | 305-243-4902 | eavisar@med.miami.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| 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 |
| D013514 | Surgical Procedures, Operative |
| D021701 | Sentinel Lymph Node Biopsy |
| D013906 | Thoracoscopy |
| D013671 | Technetium Tc 99m Sulfur Colloid |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017556 | Technetium Compounds |
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| Title | Measurements |
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