NCT07352930

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

A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer: A Prospective Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast-Conserving Surgery

Interventions

Type	Name	Description
DEVICE	EndoSCell Scanner (ES Scanner) System	The EndoSCell Scanner (ES Scanner) is an intraoperative fluorescence imaging system used during breast-conserving surgery to provide real-time, cellular-level visualization of the surgical cavity wall. During the surgery, after removing the main tumor specimen and the standard circumferential cavity shave margins, the cavity wall is locally stained with sodium fluorescein and methylene blue. Then, the ES Scanner probe is placed on the cavity wall tissue and the blue light is used to detect the fluorescence patterns related to residual cancer cells. The system processes and displays these images in real time, highlighting the areas that may contain residual cancer cells. This visual guidance aims to assist surgeons in precisely removing additional tissue margins ( "therapeutic shaves" ) from specific suspicious cavity wall locations during the initial surgery, in order to achieve a negative (no cancer) surgical margin in the first operation.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2026-01-20
• Last updated: 2026-03-24

Locations

1 site across 1 country: China