Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative
- 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
- Draw the learning curve of internal mammary sentinel lymph node biopsy.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Visualization rate of IMSLN
Visualization rate of IMSLN between conventional and modified techniques
Yong-sheng Wang, MD
Shandong Cancer Hospital
China: Ministry of Health