RecruitingNot ApplicableNCT07339306

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

Sponsor

The Fourth Affiliated Hospital of China Medical University

Enrollment

300 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Mammary Tumor Nipple Discharge

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

Female patients aged 18-75 years.
Patients scheduled to undergo duct excision surgery.
Patients who are capable of providing written informed consent and adhering to the study protocols.

Exclusion Criteria6

Pregnant or breastfeeding.
Patients who have known allergy to quantum-dot materials or localization needle components.
Patients with active hepatitis B or C infection with detectable viral load.
Patients with unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA class III-IV heart failure).
Patients with history of neurological or psychiatric disorders that may impair compliance (e.g., epilepsy, dementia).
Patients who concurrent participation in another interventional clinical trial.