Actively Recruiting
A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions
Led by The Fourth Affiliated Hospital of China Medical University · Updated on 2026-01-15
300
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-75 years
- Diagnosed with intraductal breast lesion by ductoscopy
- Have undergone ductal excision
- 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 parts
- Active hepatitis B or C infection with detectable viral load
- Unstable cardiovascular disease such as recent heart attack, uncontrolled arrhythmia, or severe heart failure
- History of neurological or psychiatric disorders that affect compliance, like epilepsy or dementia
- Currently participating 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
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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