Evaluating a New Fluorescent Needle for Precise Localization and Sampling of Small Breast Duct Lesions in Women Aged 18 to 75

What this Trial Is About

This study focuses on women with breast duct lesions, including mammary tumors, nipple discharge, and breast ductal carcinoma in situ. It evaluates a new fluorescent localization needle designed with a controllable shedding quantum dot chiral nanofluorescent coating. The goal is to compare this novel device to traditional localization methods in order to improve the accuracy of pathological diagnosis for very small breast duct microlesions, which are difficult to locate precisely during surgery and pathology assessments. Participants undergo breast duct excision surgery using either the new fluorescent localization needle or a conventional localization needle without coating. This prospective, multicenter study compares how reliably rapid pathology during surgery matches postoperative pathology when using these two localization techniques. The study aims to assess if the new needle can help surgeons and pathologists better identify tiny lesions, potentially reducing missed diagnoses and additional surgeries. During the study, participants receive surgery with one of the two localization methods and have pathological assessments performed both intraoperatively and postoperatively over a 6-week period. Researchers measure how well the rapid pathology results align with the final postoperative diagnosis. The study spans from enrollment through 6 weeks after treatment, with ongoing monitoring to evaluate the clinical usefulness of the fluorescent needle. Participation involves consenting to surgery and follow-up assessments to track diagnostic agreement and outcomes.

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