NCT01642511

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	99mTc-labeled Sulfur Colloid	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.
PROCEDURE	Axillary Sentinel Lymph Node Biopsy	Sentinel lymph node biopsy
DRUG	Methylthioninium	Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
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).
PROCEDURE	Axillary Lymph Node Dissection	ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
PROCEDURE	Internal Mammary Sentinel Lymph Node Biopsy	Internal mammary sentinel lymph node biopsy

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-11-01
• Completion: 2015-03-01
• First posted: 2012-07-17
• Last updated: 2018-04-04

Locations

1 site across 1 country: China