Breast Cancer
Conditions
Interventions
Gold Standard:Postoperative permanent paraffin pathology (H&E staining)
Index test:Interpretation of EndoSCell cell-level fluorescence scanning imaging based on margin risk stratification
Sponsors
Quanzhou first Hospital,Fujian
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Clinical Diagnosis:Patients with breast lesions highly suspicious of malignancy based on clinical examination and imaging (BI-RADS category >= 4). 2.Planned Procedure:Candidates for breast-conserving surgery (BCS) starting with intraoperative frozen section analysis. 3.Age: Female patients aged 18-75 years. 4.Consent: Voluntary signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Inflammatory breast cancer or extensive multicentric lesions unsuitable for breast-conserving surgery. 2.Previous history of ipsilateral breast surgery or radiotherapy. 3.Pregnant or lactating women. 4.Severe cardiac, pulmonary, hepatic, or renal dysfunction rendering the patient unable to tolerate surgery. 5.Known contraindications to the fluorescence imaging agents used in the study (e.g., related allergy risks). 6.Subjects with benign lesions confirmed by intraoperative frozen section.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic Performance (Sensitivity, Specificity, Accuracy);Total Intraoperative Scanning Time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Re-excision Rate; | — |
Countries
China
Contacts
Public ContactChen Debo
Quanzhou first Hospital,Fujian
Outcome results
None listed