A Novel Fluorescent Ductal Needle With Controllable Detachment for Realtime Localization and Sampling of Micro Lesions in Breast Ducts: a Prospective, Multicenter Study

What this Trial Is About

Researchers are investigating a new fluorescent localization needle designed with a controllable shedding quantum dot chiral nanofluorescent coating to improve the accuracy of locating and diagnosing tiny microlesions in breast ducts. This prospective, multicenter cohort study compares this innovative needle to traditional localization methods used during breast duct lesion surgeries. The goal is to assess how well this new device helps pathologists make precise diagnoses and reduce missed lesions, which are challenging due to the small size of lesions and the narrow breast ducts. The study involves two groups of patients undergoing breast ductal excision surgery. One group will have surgery using the novel fluorescent localization needle, while the other group will have surgery using conventional localization needles without any special coating. This comparison aims to evaluate the real-time localization effectiveness and pathological accuracy between the two methods. The study is planned to start in January 2026 and will continue until September 2026. Participants will be monitored from enrollment through six weeks after treatment, with researchers measuring the agreement rates between intraoperative rapid pathology and postoperative pathology results. The trial includes various assessments to ensure accurate sampling and localization of microlesions. Safety and adherence to study protocols will also be monitored throughout the treatment period. The study is sponsored by The Fourth Affiliated Hospital of China Medical University and involves female patients aged 18 to 75 years scheduled for duct excision surgery.

A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts