Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also
      the first-echelon nodal drainage site for metastasis and provides important prognostic
      information in breast cancer patients. The internal mammary sentinel lymph node biopsy
      (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. But
      the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical trial is
      carried out to improve the visualization rate of IMSLN with modified techniques: (1) The
      radiotracer is injected intraparenchymally into 2~4 quadrants of breast. (2) The radiotracer
      is injected in a high volume. (3) The radiotracer should be injected under ultrasonographic
      guidance.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the visualization rate of internal mammary sentinel lymph node in breast cancer
           patients with different injection technologies.

        -  Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with
           clinically axillary node -negative in these patients.

        -  Evaluate the risk factors for internal mammary sentinel lymph node metastasis

        -  Evaluate the success rate and the safety of internal mammary sentinel lymph node biopsy.

        -  Draw the learning curve of internal mammary sentinel lymph node biopsy.

      OUTLINE:

      3~18 hours before surgery, 99mTc-labeled sulfur colloid was injected under ultrasonographic
      guidance in different patterns and injection methods were classified according to the number
      of injection quadrants. Subsequently, lymphoscintigraphy was performed 0.5~1.0 hour before
      surgery. During surgery, the sentinel lymph nodes (axillary or internal mammary) were
      identified by combining the use of intraoperative gamma detector and blue dye. The sentinel
      lymph nodes (axillary or internal mammary) were analyzed by hematoxylin-eosin staining and
      immunohistochemistry for future therapy planning.
    

Intervention name(s): 99mTc-labeled Sulfur Colloid; Axillary Sentinel Lymph Node Biopsy; Methylthioninium; Lymphoscintigraphy; Axillary Lymph Node Dissection; Internal Mammary Sentinel Lymph Node Biopsy
Intervention type(s): Radiation; Procedure; Drug; Device; Procedure; Procedure
Intervention description(s): Control Group: Each patient received the 1 intraparenchymal injection of 99mTc-SC (0.5~1.0 mCi/0.5mL) in the tumor quadrant. Study Group: 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.; Sentinel lymph node biopsy; Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery; Sequential anterior and lateral gamma imaging was performed with patients lying prone and by injection side just before surgery using a digital gamma camera computer system (Toshiba GCA-901A/HG).; ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.; Internal mammary sentinel lymph node biopsy
Other intervention name(s): 99mTc-SC; SLNB; LSG; ALND; IM-SLNB
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Breast Cancer; Sentinel Lymph Node Biopsy; Internal Mammary; Lymphoscintigraphy