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

NCT06994416 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-01-15

No results posted yet for this study

Summary

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.

Conditions

  • Mammary Tumor
  • Nipple Discharge

Interventions

DEVICE

novel fluorescent localization marker needle

novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating

DEVICE

conventional localization marker needle

conventional localization marker needle, without any coating

Sponsors & Collaborators

  • The Fourth Affiliated Hospital of China Medical University

    lead OTHER

Principal Investigators

  • Jian Wen, MD · The Fourth Affiliated Hospital of China Medical University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-12-31
Completion
2026-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06994416 on ClinicalTrials.gov