Actively Recruiting
A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
Led by The Fourth Affiliated Hospital of China Medical University · Updated on 2026-01-26
300
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-75 years
- Patients scheduled to undergo duct excision surgery
- Patients able to provide written informed consent and follow study protocols
You will not qualify if you...
- Pregnant or breastfeeding
- Known allergy to quantum-dot materials or localization needle components
- Active hepatitis B or C infection with detectable viral load
- Unstable cardiovascular disease such as recent myocardial infarction, uncontrolled arrhythmia, or NYHA class III-IV heart failure
- History of neurological or psychiatric disorders impairing compliance, including epilepsy or dementia
- Participation in another interventional clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110032
Actively Recruiting
Research Team
J
Jian Wen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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