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Life sciences · Observational Study
ClinicalTrials.gov · October 13, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT06994416). This is a study registration, not published results. Lead sponsor: The Fourth Affiliated Hospital of China Medical University. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Mammary Tumor, Nipple Discharge. Interventions: DEVICE: novel fluorescent localization marker needle; DEVICE: conventional localization marker needle. Primary outcome measures: pathological assessment concordance rates , Data analysis period: June 2025- December 2025. Brief 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.