A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
Recruiting now · Not applicable
Conditions studied: Mammary Tumor, Nipple Discharge, Breast Ductal Carcinoma In Situ
In brief
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.
Key facts
- Study ID
- NCT07339306
- Run by
- The Fourth Affiliated Hospital of China Medical University
- People needed
- 300
- Starts
- 2026-01-01
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-06-11
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- The Fourth Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
Full record on ClinicalTrials.gov
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