A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer: A Prospective Randomized Controlled Trial
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.
• Pathologically confirmed diagnosis of primary invasive breast cancer, ductal carcinoma in situ (DCIS), or invasive breast cancer with a DCIS component. Acceptable diagnostic methods include core needle biopsy or fine-needle aspiration biopsy.
• Female, age ≥ 18 years.
• Scheduled to undergo breast-conserving surgery for the malignant breast lesion.
• Willing and able to comply with the study procedures and follow-up.
• Has provided written informed consent.
• No other uncontrolled serious medical conditions aside from the cancer diagnosis (see Exclusion Criteria for details).
• Adequate organ and bone marrow function, defined as:
‣ White blood cell count \> 3,000/μL
⁃ Platelet count \> 75,000/μL
⁃ Total bilirubin ≤ institutional upper limit of normal (ULN)
⁃ AST (SGOT) / ALT (SGPT) \< 2.5 × institutional ULN
⁃ Serum creatinine ≤ 1.5 mg/dL, OR creatinine clearance \> 60 mL/min/1.73 m² (for participants with serum creatinine levels above institutional ULN)
• ECOG performance status of 0 or 1.