Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node.

Study Overview
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Brief Summary
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The purpose of this study is to analysis the fluorescence image of the breast sentinel lymph node (SLN) using Indocyanine green (ICG). Moreover, to investigate whether an artificial intelligence protocol was suitable for identifying metastatic status of SLN during the surgery, and evaluate the diagnosis consistency of the AI technique and pathological examinations for lymph node with and without metastasis.

Detailed Description
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Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. But identification of metastatic LNs within the fibro-adipose tissue of the fossa axillaris specimen remains a challenge. Recently, indocyanine green (ICG) and methylene blue are commonly used in clinical practice. ICG as a fluorescent dyes, has effectiveness in mapping SLNs during surgery. Surgeons can follow the fluorescence display to detect SLN, and simultaneously capture real-time fluorescent video images. Several other groups has been demonstrated that the usage of ICG fluorescent surgical navigation system to detect SLNs in breast cancer patients is technically feasible. But no study investigate the variability between fluorescent images of breast sentinel lymph node with and without metastasis in the existing paper. Deep learning (DL) artificial intelligence (AI) algorithms in medical imaging are rapidly expanding. In this study, the investigators aim to develop and validate an easy-to-use artificial intelligence prediction model to intraoperatively identify the sentinel lymph node metastasis status. Furthermore, to explore whether this independent and parallel intraoperative lymph node assessment workflow can provide rapid and accurate skull base on lymph node fluorescent images analysis, meanwhile detecting occult lymph node (micro-) metastasis, using optical imaging and artificial intelligence.

Official Title
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Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node in Patients With Breast Cancer.

Conditions
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Breast Cancer, Sentinel Lymph Node

Intervention / Treatment
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* Drug: Indocyanine green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-70 years female. The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer. No clinical examination of suspicious axillary lymph node-positive. Preoperative clinical or radiologic evidence without distant metastases (M0). The patient has good compliance with the planned protocol during the study and signed informed consent. Exclusion Criteria: Pregnancy, breastfeeding. Allergy to ICG. Former operation or radiotherapy in the axilla or breast or thoracic wall in the same side of breast cancer. Psychiatric or cognitive impairment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Indocyanine green<br>Injection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL; Achieve Intraoperative fluorescence images by Near-Infrared I ( NIR-I ) fluorescence imaging instrument. | Drug: Indocyanine green<br>* Injection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL<br>* Other names: ICG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of lymph node metastasis | The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens. | Participants will be followed for the duration of hospital stay, an expected average of 3 months |