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Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.
In this study, our hypotheses are as following:
Indocyanine green Advantages: provides visualization of sentinel lymph node without incision
Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes
Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| radioisotope | Active Comparator | sentinel lymph node operation using radioisotope in the breast cancer patients |
|
| the mixture including indocyanine green | Experimental | sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the mixture including indocyanine green | Device | Sentinel lymph node biopsy using near-infrared imaging system and gamma probe detector for the mixture of indocyanine green, blue dye, and radioisotope during operation |
| Measure | Description | Time Frame |
|---|---|---|
| Time to sentinel lymph node biopsy | From the date of randomization, skin necrosis and dye staining are assessed up to 6 months after the operation (post op 3 mon and 6 mon follow-up). | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Identification rate of sentinel lymph node biopsy | The number of participants with sentinel lymph node detection is assessed up to 13 months. | 13 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| So-Youn Jung | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
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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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| radioisotope | Device | Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation |
|
| D017437 |
| Skin and Connective Tissue Diseases |