Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
- 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.
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
Yong-sheng Wang, MD
Shandong Cancer Hospital
China: Ministry of Health