Fluorescent duct needle to find and sample tiny breast-duct lesions
A Novel Fluorescent Ductal Needle With Controllable Detachment for Realtime Localization and Sampling of Micro Lesions in Breast Ducts: a Prospective, Multicenter Study
This study will try a fluorescent ductal needle to help surgeons find and sample tiny breast-duct lesions in women having duct excision.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | The Fourth Affiliated Hospital of China Medical University Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT07339306 on ClinicalTrials.gov |
What this trial studies
This prospective multicenter cohort compares a novel fluorescent localization needle—coated with a controllable-shedding quantum dot chiral nanofluorescent layer—to conventional localization needles for locating millimeter-scale lesions inside breast ducts. Surgeons will use the fluorescent needle during duct excision and pathologists will compare rapid intraoperative pathology results to standard postoperative pathology to measure consistency and accuracy. The study targets the technical challenge of locating lesions in ducts under 0.7 mm in diameter and aims to reduce specimen contamination and missed diagnoses. Eligible patients are adult women scheduled for duct excision who can give informed consent and comply with study procedures.
Who should consider this trial
Good fit: Women aged 18 to 75 who are scheduled for duct excision for suspected ductal lesions or nipple discharge and can provide written informed consent are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, allergic to quantum-dot materials or needle components, have active hepatitis with detectable viral load, unstable cardiac disease, or interfering neurological/psychiatric conditions are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, the device could improve accurate localization of tiny ductal lesions, lowering missed diagnoses and the need for repeat surgery.
How similar studies have performed: Fluorescent localization has been used in some breast procedures with promising results, but the controllable-shedding quantum dot ductal needle is a novel approach that has not been widely tested in clinical series.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shenyang, Liaoning
- The Fourth Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Principal investigator: Jian Wen, MD — The Fourth Affiliated Hospital of China Medical University
- Study coordinator: Jian Wen, MD
- Email: wenjian@cmu.edu.cn
- Phone: +86 18900912982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.