Cellular-Level Fluorescence Imaging for Intraoperative Margin Assessment in Breast Cancer

Accurate intraoperative margin assessment in breast cancer surgery remains challenging. Current reliance on frozen section pathology is limited by prolonged processing time, sampling constraints, and resource intensity, contributing to variable outcomes. The EndoSCell Scanner is a novel cellular-resolution fluorescence-guided imaging technology designed to address these limitations. It enables real-time, pathology-level visualization of malignant cellular features at the surgical bed. With a 3mm probe allowing comprehensive 360° margin assessment, it reduces procedural time to under five minutes and may significantly lower secondary surgery rates. This prospective, self-controlled study aims to evaluate the accuracy of the EndoSCell Scanner for intraoperative margin assessment in patients undergoing mastectomy. Its performance will be systematically compared against both frozen section and final paraffin pathology to validate sensitivity and operational efficiency. If proven effective, this technology could become a standard adjunct tool, standardizing precision in breast cancer surgery and improving patient outcomes by enhancing surgical consistency.

Sex

Female

Minimum age

18 Years

Maximum age

70 Years

Inclusion Criteria:

* Age between 18 - 70 years
* Patients scheduled for breast tumor resection
* Clinically or radiologically showing a solitary lesion and

  1. (Before neoadjuvant chemotherapy) Maximum tumor diameter ≤ 5cm;
  2. cN0-1;
  3. No clinical or imaging evidence of nipple, skin, chest wall invasion, or distant metastasis before surgery.
* Subjects voluntarily sign informed consent or are exempted from signing upon approval by the ethics committee.

Exclusion Criteria:

* Inflammatory breast cancer;
* Patients allergic to methylene blue and sodium fluorescein;
* Unable to understand the trial requirements or unable to complete the study follow-up plan;
* Pregnant and breastfeeding women;
* Patients unable to complete follow-up due to mental illness, cognitive or emotional disorders;
* Those with severe comorbidities (such as organ dysfunction, immune deficiency) or poor general condition;
* Those participating in other clinical studies that may affect this trial;
* Those for whom satisfactory specimens for both frozen pathology and paraffin pathology cannot be obtained during surgery;
* Those who cannot obtain a paraffin pathology report.