RecruitingNCT06994416

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

Sponsor

The Fourth Affiliated Hospital of China Medical University

Enrollment

300 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

Mammary Tumor Nipple Discharge

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

Female patients aged 18-75 years.
Patients who have been diagnosed intraductal breast lesion by ductoscopy.
Patients who have undergone ductal excision.
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.