A Novel Fluorescent Ductal Needle With Controllable Detachment for Real-time Localization and Sampling of High-risk Breast Micro Lesions: a Retrospective Study

What this Trial Is About

Researchers are investigating a new method to improve the accuracy of locating and diagnosing tiny breast duct lesions. This retrospective cohort study compares a novel fluorescent localization needle coated with a controllable shedding quantum dot chiral nanofluorescent layer against conventional localization techniques. The study focuses on how well this innovative needle helps pathologists identify small micro lesions in breast ducts, which are typically very challenging to detect due to their size. The study evaluates two groups: one where patients received breast duct excision surgery using the novel fluorescent localization marker needle, and another using conventional localization needles without any coating. During surgery, specimens are taken for frozen section analysis and later for detailed postoperative pathological evaluation using paraffin-embedded samples. This approach aims to compare the consistency between intraoperative and postoperative pathology results with both localization methods. Participants are female patients aged 18 to 75 years who have been diagnosed with intraductal breast lesions through ductoscopy and have undergone ductal excision. They will be monitored retrospectively, with pathological assessment concordance rates being the primary outcome measured from June to December 2025. The study will analyze how accurately each localization method helps in diagnosing breast duct micro lesions, potentially reducing missed diagnoses and the need for additional surgeries.

A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions