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

NCT06994416 | Recruiting DMC

• 1 other identifier: FourthAHChinaMU
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammary Tumor; 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.

  Data analysis period: June 2025- December 2025

Study Arms (2)

Experimental

Patients received breast ductal excision surgery utilizing a novel fluorescent localization marker needle. Specimens were submitted for intraoperative frozen section analysis as well as for postoperative paraffin-embedded pathological evaluation.

Device: novel fluorescent localization marker needle

Control

Patients received breast ductal excision surgery utilizing conventional localization methods. Specimens were submitted for intraoperative frozen section analysis as well as for postoperative paraffin-embedded pathological evaluation.

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

Experimental

conventional localization marker needle DEVICE

conventional localization marker needle, without any coating

Control

Eligibility Criteria

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

Study Population

This retrospective study estimated enroll 300 patients diagnosed with intraductal breast lesion by ductoscopy at the Fourth Affiliated Hospital of China Medical University between January 2023 and December 2024. All participants met inclusion criteria, and underwent ductal excision utilizing a novel fluorescent localization marker needle or conventional localization methods.

You may qualify if:

• Female patients aged 18-75 years.
• Patients who have been diagnosed intraductal breast lesion by ductoscopy.
• Patients who have undergone ductal excision.
• 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

Related Publications (1)

• Alshurbasi N, Cartlidge CWJ, Kohlhardt SR, Hadad SM. Predicting Patients Found to Have Malignancy at Nipple Duct Surgery. Breast Care (Basel). 2020 Oct;15(5):491-497. doi: 10.1159/000504528. Epub 2019 Dec 13.

  PMID: 33223992 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Galactorrhea

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

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: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Fifth General Surgery Department

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)