Study of a New Fluorescent Needle for Precise Localization and Sampling of High-risk Small Breast Duct Lesions

What this Trial Is About

This research evaluates a new fluorescent localization needle designed to improve the accuracy of pathological diagnosis for small breast duct micro lesions. These tiny lesions are difficult to locate precisely with current methods, risking missed diagnoses and additional surgeries. The study compares this novel device with traditional localization techniques in patients diagnosed with intraductal breast lesions who have undergone ductal excision. Participants in this retrospective study received breast ductal excision surgery using either the novel fluorescent localization needle featuring a controllable shedding quantum dot chiral nanofluorescent coating or conventional localization needles without coatings. Tissue samples from both groups were analyzed intraoperatively with frozen section analysis and postoperatively using paraffin-embedded pathological evaluation to assess diagnostic consistency. During the study, researchers analyze the concordance between intraoperative and postoperative pathological assessments to determine the clinical utility of the new fluorescent needle. The main outcome measured is the rate of agreement in pathological findings between the two sampling times. The study period covers data analysis from June to December 2025, with the overall study completion expected by May 2026. Participants are female patients aged 18 to 75 diagnosed by ductoscopy and treated with ductal excision.

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