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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indocyanine green | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green | Drug | Injection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
women aged 18-70 years
Participants were recruited from Xiang'An Hospital of Xiamen University, between November 30, 2022, and November 30, 2024.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueqi Fan, MD | Contact | 19859202604 | fanxq@stu.xmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xueqi Fan, MD | School of Medicine, Xiamen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiamen Key Laboratory of Endocrine-Related Cancer Precision Medicine | Recruiting | Xiamen | Fujian | 361000 | China |
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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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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Lymph node
| D017437 |
| Skin and Connective Tissue Diseases |