Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      OBJECTIVES:

        -  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.
    

Intervention name(s): Isosulfan blue; Axillary Lymph Node Dissection; Surgery; Sentinel Lymph Node Biopsy; Thoracoscopic Surgery; Technetium Tc 99m Sulfur Colloid
Intervention type(s): Drug; Procedure; Procedure; Procedure; Procedure; Radiation
Intervention description(s): 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.; Axillary Lymph Node Dissection; 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.; Sentinel Lymph Node Biopsy; Performed only if internal mammary sentinel node cannot be retrieved via same incision of lumpectomy/mastectomy.; 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
Other intervention name(s): Lymphazurin
Intervention MeSH terms: Technetium Tc 99m Sulfur Colloid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: stage I breast cancer; stage II breast cancer; male breast cancer