Fluorescent ductal needle to locate and sample tiny breast-duct lesions

A Novel Fluorescent Ductal Needle With Controllable Detachment for Real-time Localization and Sampling of High-risk Breast Micro Lesions: a Retrospective Study

This study tests whether a new fluorescent ductal needle helps surgeons and pathologists find and sample tiny breast-duct lesions more accurately for women undergoing ductal excision.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: The Fourth Affiliated Hospital of China Medical University (other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06994416 on ClinicalTrials.gov

What this trial studies

This retrospective cohort compares intraoperative rapid pathology versus final postoperative pathology for patients who had ductal excision using either a novel fluorescent localization needle with a controllable shedding quantum-dot chiral nanofluorescent coating or conventional localization needles. The analysis focuses on whether the fluorescent coating improves localization of millimeter-scale intraductal lesions in ducts under 0.7 mm diameter and reduces specimen contamination and missed diagnoses. Data are drawn from patient records at The Fourth Affiliated Hospital of China Medical University, with primary outcomes including concordance between rapid and postoperative pathology, rates of missed diagnoses, and subsequent need for additional surgery. The intent is to determine whether the fluorescent marker provides more reliable pathological sampling than traditional methods.

Who should consider this trial

Good fit: Women aged 18–75 diagnosed with intraductal breast lesions by ductoscopy who underwent ductal excision and can provide informed consent are the ideal candidates.

Not a fit: Pregnant or breastfeeding patients, those allergic to quantum-dot materials or needle components, patients with active detectable hepatitis B or C, unstable cardiovascular disease, significant neuropsychiatric disorders, or concurrent participation in another interventional trial are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this needle could reduce missed diagnoses of tiny duct lesions and lower the need for repeat surgery by improving localization and sampling accuracy.

How similar studies have performed: Fluorescence-guided localization has been used in other breast and surgical settings with mixed results, but a controllable quantum-dot shedding needle for intraductal micro lesions is novel and not yet widely tested.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged 18-75 years.
2. Patients who have been diagnosed intraductal breast lesion by ductoscopy.
3. Patients who have undergone ductal excision.
4. 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

Conditions: Mammary Tumor, Nipple Discharge, micro lesions, breast duct, fluorescent ductal needle, localization needle, controllable detachment