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

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing
    • Study completion pushed from Sep 30, 2026 to Dec 30, 2026
    • Eligibility criteria expanded, about 9 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07339306
Lead Sponsor The Fourth Affiliated Hospital of China Medical University
Conditions
(from sponsor)		 Mammary Tumor, Nipple Discharge, Breast Ductal Carcinoma In Situ
Related terms Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Galactorrhea
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov