NCT07029646

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 167 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast-Conserving Surgery
• Breast Carcinoma
• Margins in the Specimen

Interventions

Type	Name	Description
DEVICE	EndoScell™ intraoperative handheld microscope	The research instrument used is the EndoScell™ intraoperative handheld microscope, which employs the principle of epifluorescence. It is a miniaturized microscope that reduces the size of a traditional large optical microscope by approximately a thousand times. It is the world's first handheld micrometer-level intraoperative real-time cell imaging probe microscope. This microscope is equipped with high-definition, real-time, anti-shake, and full-coverage scanning features. It can rapidly investigate the structure and cell morphology of tissues in real-time.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2025-06-19
• Last updated: 2025-06-19