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

NCT07339306 | Recruiting DMC

• 1 other identifier: FourthAHChinaMU-PMS
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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; Breast Ductal Carcinoma In Situ; Nipple Discharge

Keywords

micro lesions; breast duct; fluorescent ductal needle; localization needle; controllable detachment

Outcome Measures

Primary Outcomes (1)

• pathological assessment concordance rates

  Evaluate and compare the discrepancies in the consistency of intraoperative frozen and postoperative paraffin-embedded pathological assessments between subjects undergoing breast duct excision surgery utilizing a novel fluorescent localization marker needle and those employing conventional localization methods.

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Fluorescent Localization Group

EXPERIMENTAL

Patients received breast ductal excision surgery utilizing a novel fluorescent localization marker needle.

Device: novel fluorescent localization marker needle

Conventional Localization Group

ACTIVE COMPARATOR

Patients received breast ductal excision surgery utilizing conventional localization methods.

Device: conventional localization marker needle

Interventions

novel fluorescent localization marker needle DEVICE

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

Fluorescent Localization Group

conventional localization marker needle DEVICE

conventional localization marker needle, without any coating

Conventional Localization Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-75 years.
• Patients scheduled to undergo duct excision surgery.
• Patients who are capable of providing written informed consent and adhering to the study protocols.

You may not qualify if:

• 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).
• Patients with history of neurological or psychiatric disorders that may impair compliance (e.g., epilepsy, dementia).
• Patients who concurrent participation in another interventional clinical trial.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of China Medical University: lead

Study Sites (1)

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Galactorrhea; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lactation Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Jian Wen, MD

  The Fourth Affiliated Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Wen, MD

CONTACT

+86 18900912982; wenjian@cmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Ninth General Surgery Department

Model Details: Experimental Group: Patients received breast ductal excision surgery utilizing a novel fluorescent localization marker needle. Control Group: Patients received breast ductal excision surgery utilizing conventional localization methods.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)