NCT01668914

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.

Detailed description

OBJECTIVES: * 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. OUTLINE: 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	IM-SLNB	IM-SLNB is performed according to the pre-operative lymphoscintigraphy
RADIATION	99mTc-SC	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.
DEVICE	Histologic Examination	All IMSLNs were analyzed by histologic examination for future therapy planning.
DEVICE	LSG	lymphoscintigraphy was performed 0.5\~1.0 hour before surgery
DRUG	Methylthioninium	Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-09-01
• Completion: 2017-12-01
• First posted: 2012-08-20
• Last updated: 2018-04-05

Locations

1 site across 1 country: China