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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clinically positive axillary nodes | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IM-SLNB | Procedure | IM-SLNB is performed according to the pre-operative lymphoscintigraphy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB | Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Visualization Rate of IMSLNs | visualization rate of internal mammary hotspots in lymphoscintigraphy | 1 year |
| Metastasis Rate of IMSLNs | Metastasis Rate of internal mammary sentinel lymph node |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong-sheng Wang, MD | Shandong Cancer Hospital and Institute | Study Chair |
| Peng-fei Qiu, MD | Shandong Cancer Hospital and Institute | Principal Investigator |
| Yan-bing Liu, MD | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D006652 | Histological Techniques |
| D007150 | Immunohistochemistry |
| D061305 | Lymphoscintigraphy |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| 99mTc-SC | Radiation | 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. |
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| Histologic Examination | Device | All IMSLNs were analyzed by histologic examination for future therapy planning. |
|
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| LSG | Device | lymphoscintigraphy was performed 0.5~1.0 hour before surgery |
|
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| Methylthioninium | Drug | Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery |
|
| 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D007158 | Immunologic Techniques |
| D011877 | Radionuclide Imaging |
| D003952 | Diagnostic Imaging |
| D003947 | Diagnostic Techniques, Radioisotope |