Thoracoscopic Internal Mammary Sentinel Node Biopsy
- Determine the occurrence rate of internal mammary sentinel lymph nodes in patients with
medially or centrally located stage I or II breast cancer.
- Determine the safety, feasibility, and success rate of thorascopic internal mammary
sentinel lymph node biopsy in these patients.
- Determine the rate of metastatic disease in internal mammary sentinel lymph nodes
obtained thoracoscopically in these patients.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Success Rate in Removing Sentinel Lymph Nodes by Thoracoscopy
Eli Avisar, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
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