Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative (IMSLNB-EBCP)

• Metastasis Rate of IMSLN [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB
• Frequency and Severity of Complications with IM-SLNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Success rate of IM-SLNB [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.

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.

• Radiation: 99mTc-labeled Sulfur Colloid
  Each patient received the 1 intraparenchymal injection of 99mTc-SC (0.5~1.0 mCi/0.5mL) in the tumor quadrant.
  Other Name: 99mTc-SC
• Radiation: 99mTc-labeled Sulfur Colloid
  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.
  Other Name: 99mTc-SC
• Procedure: Axillary Sentinel Lymph Node Biopsy
  Sentinel lymph node biopsy
  Other Name: SLNB
• Drug: Methylthioninium
  Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
  Other Name: methylthioninium
• Device: Lymphoscintigraphy
  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).
  Other Name: LSG
• Procedure: Axillary Lymph Node Dissection
  ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
  Other Name: ALND
• Procedure: Internal Mammary Sentinel Lymph Node Biopsy
  Internal mammary sentinel lymph node biopsy
  Other Name: IM-SLNB

• Active Comparator: Control Group
  conventional technique: 99mTc-labeled Sulfur Colloid was injected into the tumor quadrant.
  Interventions:

  • Radiation: 99mTc-labeled Sulfur Colloid
  • Procedure: Axillary Sentinel Lymph Node Biopsy
  • Drug: Methylthioninium
  • Device: Lymphoscintigraphy
  • Procedure: Axillary Lymph Node Dissection
  • Procedure: Internal Mammary Sentinel Lymph Node Biopsy
• Experimental: Study Group
  modified technique: 99mTc-labeled Sulfur Colloid was injected into 2 quadrants of the breast.
  Interventions:

  • Radiation: 99mTc-labeled Sulfur Colloid
  • Procedure: Axillary Sentinel Lymph Node Biopsy
  • Drug: Methylthioninium
  • Device: Lymphoscintigraphy
  • Procedure: Axillary Lymph Node Dissection
  • Procedure: Internal Mammary Sentinel Lymph Node Biopsy

Inclusion Criteria:

• primary breast cancer
• clinically axilla-negative

Exclusion Criteria:

• enlarged internal mammary nodes by imaging