A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
Recruiting · NCT07339306 · Interventional (participants receive a specific treatment) · Lead sponsor: The Fourth Affiliated Hospital of China Medical University
View the official record on ClinicalTrials.gov →Interventions studied
conventional localization marker needlenovel fluorescent localization marker needle
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Female patients aged 18-75 years.
- Patients scheduled to undergo duct excision surgery.
- Patients who are capable of providing written informed consent and adhering to the study protocols.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- The Fourth Affiliated Hospital of China Medical University - Shenyang, Liaoning, China