Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aimed to compare detection rate between dual sentinel node staining method using
      mixture of indocyanine green (ICG) with radioisotope(RI), and RI only.

      To identify the first lymph node(s) along the lymphatic drainage pathway from the primary
      tumor in the breast cancer using RI only has several disadvantages such as invisibility,
      interference. As ICG can be visualized with a fluorescence imaging system, we expects dual
      sentinel lymph node staining method had better outcomes.
    

Detailed description: 
      Using mixture of indocyanine green (ICG) with radioisotope (RI) can guide surgeons to
      identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor
      in the breast to the axillary lymph node basin.

      Last pilot study, sentinel lymph node was successfully identified by using dual method of ICG
      and RI in 5 patients. In this study, when radiolabeled colloid is used, a gamma probe
      identifies radioactivity in the lymph nodes in the axilla. If ICG, RI both used, Near
      infrared fluorescence camera visualized during surgery.

      As investigators measure node detection time from axillary approach moment, investigators are
      going to compare detection rate. (ICG+RI or RI only). And determine the accuracy.

      Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was
      recommended to maximize the likelihood of SLN identification and to minimize the possibility
      of missing SLNs, which could result in a false-negative event.The protocol required that 130
      patients who receive neoadjuvant chemotherapy.

      In this study investigators expects using mixture of indocyanine green (ICG) with
      radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer
      patients who receive neoadjuvant chemotherapy.

      Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was
      recommended to maximize the likelihood of SLN identification and to minimize the possibility
      of missing SLNs, which could result in a false-negative event.
    

Intervention name(s): Indocyanine green; Radioisotope
Intervention type(s): Drug; Drug
Intervention description(s): ICG is cyanine dye used in medical diagnostics. It is used for determining cardiac output, hepatic function, and liver blood flow, and for ophthalmic angiography.
In this study, Investigator uses ICG as a fluorescent dye which is used in medicine as an indicator substance . And it will allow detection of SLN more convenientlty.; Nuclear medicine uses radiation to provide diagnostic information about the functioning of a person's specific organs, or to treat them. Diagnostic procedures using radioisotopes are now routine.
Other intervention name(s): ICG; RI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Neoadjuvant chemotherapy; Indocyanine green (ICG); Radioisotope (RI); Near infrared fluorescence camera