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

NCT ID: NCT07339306

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-09-30

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.

Detailed Description

The diameter of breast ducts is less than 0.7 mm, presenting a significant technical challenge for the precise localization of early-stage, small lesions during surgical and pathological sampling. These early microlesions typically measure only a few millimeters, necessitating surgeons to increase excision margins to minimize the risk of overlooking them. However, this approach complicates the pathologists' ability to accurately identify these microlesions during diagnosis, thereby increasing the likelihood of missed diagnoses and the potential need for additional surgical interventions. Current localization methods, including liquid methylene blue and conventional localization needles, exhibit a high rate of pathological missed diagnoses due to localization inaccuracies and specimen contamination. Consequently, there is an urgent need to develop innovative localization technologies capable of facilitating the precise identification of millimeter-scale microlesions within breast ducts. A prospective multicenter study is required to compare the consistency of intraoperative and postoperative pathological assessments between a novel fluorescent localization needle-featuring a controllable shedding quantum dot chiral nanofluorescent coating-and traditional localization techniques employed in breast duct lesion surgeries. The primary objective is to evaluate the clinical efficacy of this new fluorescent localization needle in enhancing the accuracy of pathological diagnosis of microlesions within breast ducts and to improve the precision of pathological evaluations.

Conditions

Mammary Tumor; Nipple Discharge; Breast Ductal Carcinoma In Situ

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Fluorescent Localization Group

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

Group Type: EXPERIMENTAL

novel fluorescent localization marker needle

Intervention Type: DEVICE

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

Conventional Localization Group

Patients received breast ductal excision surgery utilizing conventional localization methods.

Group Type: ACTIVE_COMPARATOR

conventional localization marker needle

Intervention Type: DEVICE

conventional localization marker needle, without any coating

Interventions

novel fluorescent localization marker needle

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

Intervention Type: DEVICE

conventional localization marker needle

conventional localization marker needle, without any coating

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Female patients aged 18-75 years.

2. Patients scheduled to undergo duct excision surgery.

3. Patients who are capable of providing written informed consent and adhering to the study protocols.

Exclusion Criteria

1. Pregnant or breastfeeding.

2. Patients who have known allergy to quantum-dot materials or localization needle components.

3. Patients with active hepatitis B or C infection with detectable viral load.

4. Patients with unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, NYHA class III-IV heart failure).

5. Patients with history of neurological or psychiatric disorders that may impair compliance (e.g., epilepsy, dementia).

6. Patients who concurrent participation in another interventional clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Fourth Affiliated Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

JIAN WEN

Director of the Ninth General Surgery Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Wen, MD

Role: PRINCIPAL_INVESTIGATOR

The Fourth Affiliated Hospital of China Medical University

Locations

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jian Wen, MD

Role: CONTACT

wenjian@cmu.edu.cn

+86 18900912982

Facility Contacts

Jian Wen, MD

Role: primary

wenjian@cmu.edu.cn

+86 18900912982

Other Identifiers

FourthAHChinaMU-PMS

Identifier Type: -

Identifier Source: org_study_id