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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: 99mTc-labeled Sulfur Colloid
* Procedure: Axillary Sentinel Lymph Node Biopsy
* Drug: Methylthioninium
* Device: Lymphoscintigraphy
* Procedure: Axillary Lymph Node Dissection
* Procedure: Internal Mammary Sentinel Lymph Node Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary breast cancer clinically axilla-negative Exclusion Criteria: enlarged internal mammary nodes by imaging

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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. | Radiation: 99mTc-labeled Sulfur Colloid<br>* 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.<br>* Other names: 99mTc-SC;Procedure: Axillary Sentinel Lymph Node Biopsy<br>* Sentinel lymph node biopsy<br>* Other names: SLNB;Drug: Methylthioninium<br>* Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery<br>Device: Lymphoscintigraphy<br>* 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).<br>* Other names: LSG;Procedure: Axillary Lymph Node Dissection<br>* ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.<br>* Other names: ALND;Procedure: Internal Mammary Sentinel Lymph Node Biopsy<br>* Internal mammary sentinel lymph node biopsy<br>* Other names: IM-SLNB;|
| Experimental: Study Group<br>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. | Procedure: Axillary Sentinel Lymph Node Biopsy<br>* Sentinel lymph node biopsy<br>* Other names: SLNB;Drug: Methylthioninium<br>* Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery<br>Device: Lymphoscintigraphy<br>* 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).<br>* Other names: LSG;Procedure: Axillary Lymph Node Dissection<br>* ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.<br>* Other names: ALND;Procedure: Internal Mammary Sentinel Lymph Node Biopsy<br>* Internal mammary sentinel lymph node biopsy<br>* Other names: IM-SLNB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualization rate of IMSLN | Visualization rate of IMSLN between conventional and modified techniques | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastasis Rate of IMSLN | Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB | 15 months | 
| Frequency and Severity of Complications with IM-SLNB | IM-SLNB complications in the patients who receive IM-SLNB | 1 year | 
| Success rate of IM-SLNB | Success rate of IM-SLNB in the IMSLN visualization patients who receive IM-SLNB | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Sentinel Lymph Node Biopsy, Internal Mammary, Lymphoscintigraphy