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Recruiting NCT05623280

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

Conditions: Breast Cancer, Sentinel Lymph Node

Sex: Female
Ages: 18 Years – 70 Years
Enrollment: 40
Sponsor: Xiang'an Hospital of Xiamen University

Location: China

Summary

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05623280). StuddyBuddy aggregates publicly available trial information.