Clinical Trial

A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer

Recruiting
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Summary
The goal of this clinical trial is to learn if a novel intraoperative fluorescence-guided system (EndoSCell Scanner) can help surgeons more accurately remove all cancerous tissue during breast-conserving surgery in female patients aged 18 years or older, with primary breast cancer. The main questions it aims to answer are: * Does the use of the EndoSCell Scanner system lower the rate of secondary surgeries needed due to positive cancer margins after the initial operation? * How accurate is the EndoSCell Scanner system in detecting residual cancer cells on the walls of the surgical cavity during the operation? Researchers will compare the surgical outcomes using the EndoSCell Scanner guidance to the expected outcomes from standard surgical practice without this technology to see if the system is effective. Participants will: * Receive their planned breast-conserving surgery (lumpectomy). * Have their surgical cavity scanned with the EndoSCell Scanner device after the main tumor is removed. * Have additional tissue removed from the cavity wall if the scanner indicates a potential cancer residue.
Protocol Amendment History 1 change
critical Recruitment opened 2026-06-30
Trial Details
NCT Number NCT07352930
Lead Sponsor Guangdong Provincial People's Hospital
Conditions Breast-Conserving Surgery
Enrollment 172 participants
Start Date 2026-04-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-29