Comparative Research on the Accuracy of Margin Interpretation in Breast-Conserving Surgery for Breast Cancer: Cell Microscopic Imaging and Standard Frozen Pathology

The goal of this clinical trial is to assess whether cell microscopic imaging can accurately determine the tumor-free status of surgical margins in breast cancer patients undergoing breast-conserving surgery. This study involves female patients aged 18-70 years with breast cancer who are candidates for breast-conserving surgery. The main question it aims to answer is: \- Can cell microscopic imaging provide accurate intraoperative assessment of surgical margins compared to standard frozen pathology? Researchers will compare the results of cell microscopic imaging to those of standard frozen pathology and paraffin pathology to see if the new imaging technology can effectively and quickly determine whether surgical margins are free of cancer cells. Participants will: * Undergo breast-conserving surgery with standard pathological assessments. * Have their surgical margins evaluated using cell microscopic imaging during the operation. * Be monitored for postoperative recovery at regular intervals (2 weeks, 3 months, 6 months, and 12 months) after the surgery.

NCT Number	NCT07029646
Lead Sponsor	Peking University Cancer Hospital & Institute
Conditions	Breast-Conserving Surgery, Breast Carcinoma, Margins in the Specimen
Enrollment	167 participants
Start Date	2025-07-01
Primary Completion	2026-06-30 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-06-19