NCT06994416

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• 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 retrospective 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 primary goal is to evaluate the clinical effectiveness of this innovative fluorescent localization needle in facilitating accurate pathological diagnoses of micro lesions situated within breast ducts.

Detailed description

The diameter of breast ducts is less than 0.7 mm, which poses a considerable technical challenge in the accurate localization of early-stage small lesions during surgical and pathological sampling. These early micro lesions typically measure on the millimeter scale, necessitating an increased excision margin by surgeons to reduce the risk of overlooking them. However, this practice complicates the pathologists' ability to accurately identify these micro lesions during diagnosis, thereby heightening the likelihood of missed diagnoses and the potential for additional surgeries for patients. Current localization methods, such as liquid methylene blue and traditional localization needles, demonstrate a high rate of pathological missed diagnoses due to inaccuracies in localization and specimen contamination. Therefore, there is an urgent need for the development of innovative localization technologies that can facilitate the precise identification of millimeter-scale micro lesions within breast ducts and improve the accuracy of pathological sampling. This study aims to conduct a retrospective analysis to compare the consistency of intraoperative and postoperative pathological assessments between a novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating, and conventional localization techniques used during breast duct lesion surgeries. The objective is to evaluate the clinical utility of the new fluorescent localization needle in the accurate pathological diagnosis of micro lesions within breast ducts and to enhance the precision of pathological assessments.

Conditions

• Mammary Tumor
• Nipple Discharge

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: 2025-06-01
• Primary completion: 2025-12-31
• Completion: 2026-05-31
• First posted: 2025-05-29
• Last updated: 2026-01-15

Locations

1 site across 1 country: China