This retrospective cohort study investigates the differences in the reliability of rapid pathology compared to postoperative pathology when utilizing a novel fluorescent localization needle equipped with a controllable shedding quantum dot chiral nanofluorescent coating, in contrast to traditional localization techniques for breast duct lesions. The primary goal is to evaluate the clinical effectiveness of this innovative fluorescent localization needle in facilitating accurate pathological diagnoses of micro lesions situated within breast ducts.
Female patients aged 18-75 years.
Patients who have been diagnosed intraductal breast lesion by ductoscopy.
Patients who have undergone ductal excision.
Pregnant or breastfeeding.
Patients who have known allergy to quantum-dot materials or localization needle components.
Patients with active hepatitis B or C infection with detectable viral load.
Patients with unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA class III-IV heart failure).
This retrospective study estimated enroll 300 patients diagnosed with intraductal breast lesion by ductoscopy at the Fourth Affiliated Hospital of China Medical University between January 2023 and December 2024. All participants met inclusion criteria, and underwent ductal excision utilizing a novel fluorescent localization marker needle or conventional localization methods.
Cohort
Retrospective
novel fluorescent localization marker needle
Devicenovel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating
conventional localization marker needle
Deviceconventional localization marker needle, without any coating
pathological assessment concordance rates
Evaluate and compare the discrepancies in the consistency of intraoperative frozen and postoperative paraffin-embedded pathological assessments between subjects undergoing breast duct excision surgery utilizing a novel fluorescent localization marker needle and those employing conventional localization methods.
Click on the lead sponsor to view all of their trials.
