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

Shandong First Medical University

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Device: LSG; Device: Histologic Examination; Drug: Methylthioninium; Radiation: 99mTc-SC; Procedure: IM-SLNB

Study type: Interventional

Funder types: Other

Identifiers

NCT01668914

IMSN002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary breast cancer
• clinically axilla-positive

Exclusion criteria

• enlarged internal mammary nodes by imaging

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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126 participants in 1 patient group

clinically positive axillary nodes

Experimental group

Description:

3\~18 hours before surgery, under ultrasonographic guidance, 0.5\~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2\~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5\~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination

Treatment:

Drug: Methylthioninium

Procedure: IM-SLNB

Device: LSG

Device: Histologic Examination

Radiation: 99mTc-SC