ICG and Blue Dye Guided Sentinel Lymph Node Biopsy in Patients Underwent Neoadjuvant Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy Using the Navigation of the Combination of Indocyanine and Blue Dye in Patients With Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: ICG+Methylene Blue


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients indicated for neoadjuvant therapy Have complete evaluation of the axillary status Planned for axillary clearance after neoadjuvant therapy Exclusion Criteria: Sensitive to Iodine Inflammatory disease Patient's refusal to join the trial

Ages Eligible for Study
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Minimum Age: 20 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICG+Methylene Blue<br>ICG+Methylene Blue: Sentinel Lymph Node (SLN) identification and resection using dual tracer technique with the sub-areolar injection of ICG+Blue dye, before surgery. | Procedure: ICG+Methylene Blue<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of SLN | The number of successful SLNB / total number of SLNB | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False negative rate of SLNB | The number of patients with positive SLN / the number of patients with positive node | 1 week after the surgery | 
| Adverse effect | Prophylaxis reaction, skin complication | Half a year after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methylene blue, Indocyanine green, Neoadjuvant Therapy, Sentinel Lymph Node Biopsy, Breast Neoplasms