novel fluorescent localization marker needle: novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating
conventional localization marker needle: conventional localization marker needle, without any coating
Study 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
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Female patients aged 18-75 years.
2. Patients scheduled to undergo duct excision surgery.
3. Patients who are capable of providing written informed consent and adhering to the study protocols.
Exclusion Criteria:
1. Pregnant or breastfeeding.
2. Patients who have known allergy to quantum-dot materials or localization needle components.
3. Patients with active hepatitis B or C infection with detectable viral load.
4. Patients with unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA class III-IV heart failure).
5. Patients with history of neurological or psychiatric disorders that may impair compliance (e.g., epilepsy, dementia).
6. Patients who concurrent participation in another interventional clinical trial.
Primary outcome measure(s)
pathological assessment concordance rates — From enrollment to the end of treatment at 6 weeks Evaluate and compare the discrepancies in the consistency of intraoperative frozen and postoperative paraffin-embedded pathological assessments between subjects undergoing breast duct excision surgery utilizing a novel fluorescent localization marker needle and those employing conventional localization methods.
Trial sites (1)
Facility
City
Region
Status
The Fourth Affiliated Hospital of China Medical University
Shenyang
Liaoning
Recruiting
More The Fourth Affiliated Hospital of China Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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