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Prediction of Sentinel Lymph Node Metastasis in Breast Cancer Based on Artificial Intelligence Analysis of Intraoperative Fluorescence Imaging

Prediction of Sentinel Lymph Node Metastasis in Breast Cancer Based on Artificial Intelligence Analysis of Intraoperative Fluorescence Imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110979
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Gold Standard:Histopathological diagnosis based on postoperative paraffin-embedded sections.
Index test:Intraoperative Sentinel Lymph Node Diagnosis System for Breast Cancer Based on Intraoperative Fluorescence Imaging and Deep Learning

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years. 2.Female patients with breast cancer. 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4.Clinical stage cT1-4N0-1M0.

Exclusion criteria

Exclusion criteria: 1.Pregnancy. 2.Severe cardiopulmonary dysfunction or coagulation disorders, rendering the patient unable to tolerate neoadjuvant therapy, biopsy, or surgical procedures. 3.Presence of internal mammary, supraclavicular, or infraclavicular lymph node metastasis.

Design outcomes

Primary

MeasureTime frame
FNR;Area Under the ROC Curve;NPV;—

Secondary

MeasureTime frame
Intraoperative decision-making time;—

Countries

China

Contacts

Public ContactBin Hua

Beijing hospital

huabinbjh@126.com+86 136 9329 4508

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026