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

The Fourth Affiliated Hospital of China Medical University

Status: Enrolling

Conditions: Nipple Discharge; Mammary Tumor; Breast Ductal Carcinoma In Situ

Treatments: Device: conventional localization marker needle; Device: novel fluorescent localization marker needle

Study type: Interventional

Funder types: Other

Identifiers

NCT07339306

FourthAHChinaMU-PMS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Fluorescent Localization Group

Experimental group

Description:

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

Treatment:

Device: novel fluorescent localization marker needle

Conventional Localization Group

Active Comparator group

Description:

Patients received breast ductal excision surgery utilizing conventional localization methods.

Treatment:

Device: conventional localization marker needle