Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is
      another important lymphatic channel of the breast. The status of IMLNs also provides
      important prognostic information for breast cancer patients. The technical evolvements of
      sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for
      assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was
      performed in the patients with clinically negative axillary nodes. However, previous
      published studies concerning patients with breast cancer who all underwent a radical
      mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary
      metastases. For this reason, IM-SLNB is even more important for clinically axillary
      node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early
      breast cancer patients with clinically positive axillary nodes.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the impact of routinely performed internal mammary sentinel lymph node biopsy
           on the systemic and locoregional treatments plan.

        -  Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with
           clinically axillary node-positive.

        -  Draw the learning curve of internal mammary sentinel lymph node biopsy.

      OUTLINE:

      3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-labeled sulfur
      colloid in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2
      quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5~1.0 hour before
      surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the
      internal mammary sentinel lymph nodes were sent to histologic examination.
    

Intervention name(s): IM-SLNB; 99mTc-SC; Histologic Examination; LSG; Methylthioninium
Intervention type(s): Procedure; Radiation; Device; Device; Drug
Intervention description(s): IM-SLNB is performed according to the pre-operative lymphoscintigraphy; Two syringes of 0.25~0.5 mCi 99mTc-SC in 0.2~1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o'clock positions.; All IMSLNs were analyzed by histologic examination for future therapy planning.; lymphoscintigraphy was performed 0.5~1.0 hour before surgery; Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery
Other intervention name(s): Internal Mammary Sentinel Lymph Node Biopsy; 99mTc-labeled Sulfur Colloid; hematoxylin-eosin staining and immunohistochemistry; Lymphoscintigraphy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Breast Cancer; Clinically Axillary Node -Positive; Sentinel Lymph Node Biopsy; Internal Mammary