A Novel Fluorescent Ductal Needle for Localization and Sampling of High-risk Breast Micro Lesions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-75
SponsorThe Fourth Affiliated Hospital of China Medical University

About this trial

This retrospective 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 primary goal is to evaluate the clinical effectiveness of this innovative fluorescent localization needle in facilitating accurate pathological diagnoses of micro lesions situated within breast ducts.

Eligibility criteria

Qualifiers

Female patients aged 18-75 years.

Patients who have been diagnosed intraductal breast lesion by ductoscopy.

Patients who have undergone ductal excision.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • novel fluorescent localization marker needle
  • conventional localization marker needle

Treatment groups

300 Participants
are divided into 2 treatment groups