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A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts

NCT07339306 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-01-26

No results posted yet for this study

Summary

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.

Conditions

  • Mammary Tumor
  • Nipple Discharge
  • Breast Ductal Carcinoma In Situ

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-06-30
Completion
2026-09-30

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 NCT07339306 on ClinicalTrials.gov