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

Shandong First Medical University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: Internal Mammary Sentinel Lymph Node Biopsy; Device: Lymphoscintigraphy; Radiation: 99mTc-labeled Sulfur Colloid; Procedure: Axillary Sentinel Lymph Node Biopsy; Drug: Methylthioninium; Procedure: Axillary Lymph Node Dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT01642511

IMSN001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 407 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary breast cancer
• clinically axilla-negative

Exclusion criteria

• enlarged internal mammary nodes by imaging

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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407 participants in 2 patient groups

Control Group

Active Comparator group

Description:

conventional technique: 99mTc-labeled Sulfur Colloid was injected into the tumor quadrant 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery. Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery. Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery. Axillary lymph node dissection was performed if ASLN was positive.

Treatment:

Drug: Methylthioninium

Procedure: Axillary Lymph Node Dissection

Procedure: Axillary Sentinel Lymph Node Biopsy

Device: Lymphoscintigraphy

Radiation: 99mTc-labeled Sulfur Colloid

Procedure: Internal Mammary Sentinel Lymph Node Biopsy

Study Group

Experimental group

Description:

modified technique: 99mTc-labeled Sulfur Colloid was injected into 2 quadrants of the breast 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery. Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery. Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery. Axillary lymph node dissection was performed if ASLN was positive.

Treatment:

Drug: Methylthioninium

Procedure: Axillary Lymph Node Dissection

Procedure: Axillary Sentinel Lymph Node Biopsy

Device: Lymphoscintigraphy

Procedure: Internal Mammary Sentinel Lymph Node Biopsy