Spots Global Cancer Trial Database for Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

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Trial Identification

Brief Title: Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

Official Title: Phase II Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

Study ID: NCT01642511

Conditions

Breast Cancer

Interventions

99mTc-labeled Sulfur Colloid

Axillary Sentinel Lymph Node Biopsy

Methylthioninium

Lymphoscintigraphy

Axillary Lymph Node Dissection

Internal Mammary Sentinel Lymph Node Biopsy

Study Description

Brief 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.