Breast Cancer Clinical Trial
Official title:
Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node in Patients With Breast Cancer.
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Xiamen Key Laboratory of Endocrine-Related Cancer Precision Medicine | Xiamen | Fujian |
Lead Sponsor | Collaborator |
---|---|
Xiang'an Hospital of Xiamen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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