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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of needle that uses fluorescent (glowing) technology to locate and sample tiny, potentially dangerous lesions inside the milk ducts of the breast. The goal is to improve how surgeons find and remove these hard-to-see abnormalities. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have been diagnosed with an intraductal breast lesion (an abnormality inside a breast milk duct) found by ductoscopy (a small camera procedure) - You have already had a ductal excision procedure **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a known allergy to the needle components or quantum-dot materials - You have an active hepatitis B or C infection - You have unstable heart disease (e.g., recent heart attack or severe heart failure) - You have a neurological or psychiatric condition that would affect your ability to follow the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEnovel fluorescent localization marker needle

novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating

DEVICEconventional localization marker needle

conventional localization marker needle, without any coating


Locations(1)

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

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NCT06994416


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