The value of sentinel lymph node biopsy (SLNB) in patients underwent neoadjuvant chemotherapy is controversial. Lower detection rate and higher false negative rate are the main problem. The purpose of this study is to determine the detection rate and the false negative rate of SLNB by indocyanine green (ICG) in addition to blue dye (methylene blue) after neoadjuvant chemotherapy in patients with large or locally advanced breast cancer. This is a single arm clinical trial.
Patients indicated for neoadjuvant therapy would be recruited in this study. During the surgery, SLNB using the dual tracing method would be applied before axillary clearance. After the surgery, histological results of the SLN and non-SLN would be analysed.
Study Type
OBSERVATIONAL
Enrollment
150
ICG+Methylene Blue Arm: One ml of methylene blue (1%) would be in injected sub-areolarly 5 minutes before surgery, and 1ml of ICG (0.125%) in the same site 3 minutes later. Massage of the breast would be applied to facilitate the movement of the tracers. A small incision would be made in the axilla, and a special device would be used to search the light nodes. During the sampling, blue nodes would also be resected . After the completion of SLNB, complete axillary dissection would be carried out.
Breast Center, Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGDetection rate of SLN
The number of successful SLNB / total number of SLNB
Time frame: Immediate
False negative rate of SLNB
The number of patients with positive SLN / the number of patients with positive node
Time frame: 1 week after the surgery
Adverse effect
Prophylaxis reaction, skin complication
Time frame: Half a year after the surgery
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