NCT07339306

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: The Fourth Affiliated Hospital of China Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective, multicenter 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 principal objective is to assess the clinical efficacy of this innovative fluorescent localization needle in enabling precise pathological diagnosis of micro lesions in breast ducts.

Detailed description

The diameter of breast ducts is less than 0.7 mm, presenting a significant technical challenge for the precise localization of early-stage, small lesions during surgical and pathological sampling. These early microlesions typically measure only a few millimeters, necessitating surgeons to increase excision margins to minimize the risk of overlooking them. However, this approach complicates the pathologists' ability to accurately identify these microlesions during diagnosis, thereby increasing the likelihood of missed diagnoses and the potential need for additional surgical interventions. Current localization methods, including liquid methylene blue and conventional localization needles, exhibit a high rate of pathological missed diagnoses due to localization inaccuracies and specimen contamination. Consequently, there is an urgent need to develop innovative localization technologies capable of facilitating the precise identification of millimeter-scale microlesions within breast ducts. A prospective multicenter study is required to compare the consistency of intraoperative and postoperative pathological assessments between a novel fluorescent localization needle-featuring a controllable shedding quantum dot chiral nanofluorescent coating-and traditional localization techniques employed in breast duct lesion surgeries. The primary objective is to evaluate the clinical efficacy of this new fluorescent localization needle in enhancing the accuracy of pathological diagnosis of microlesions within breast ducts and to improve the precision of pathological evaluations.

Conditions

• Mammary Tumor
• Nipple Discharge
• Breast Ductal Carcinoma In Situ

Interventions

Type	Name	Description
DEVICE	novel fluorescent localization marker needle	novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating
DEVICE	conventional localization marker needle	conventional localization marker needle, without any coating

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2026-01-14
• Last updated: 2026-01-26

Locations

1 site across 1 country: China