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

The Fourth Affiliated Hospital of China Medical University

Status: Enrolling

Conditions: Nipple Discharge; Mammary Tumor

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

Study type: Observational

Funder types: Other

Identifiers

NCT06994416

FourthAHChinaMU

Details and patient eligibility

About

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.

Full description

The diameter of breast ducts is less than 0.7 mm, which poses a considerable technical challenge in the accurate localization of early-stage small lesions during surgical and pathological sampling. These early micro lesions typically measure on the millimeter scale, necessitating an increased excision margin by surgeons to reduce the risk of overlooking them. However, this practice complicates the pathologists' ability to accurately identify these micro lesions during diagnosis, thereby heightening the likelihood of missed diagnoses and the potential for additional surgeries for patients. Current localization methods, such as liquid methylene blue and traditional localization needles, demonstrate a high rate of pathological missed diagnoses due to inaccuracies in localization and specimen contamination. Therefore, there is an urgent need for the development of innovative localization technologies that can facilitate the precise identification of millimeter-scale micro lesions within breast ducts and improve the accuracy of pathological sampling. This study aims to conduct a retrospective analysis to compare the consistency of intraoperative and postoperative pathological assessments between a novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating, and conventional localization techniques used during breast duct lesion surgeries. The objective is to evaluate the clinical utility of the new fluorescent localization needle in the accurate pathological diagnosis of micro lesions within breast ducts and to enhance the precision of pathological assessments.

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 who have been diagnosed intraductal breast lesion by ductoscopy.
3. Patients who have undergone ductal excision.
4. 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

300 participants in 2 patient groups

Experimental

Description:

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.

Treatment:

Device: novel fluorescent localization marker needle

Control

Description:

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.

Treatment:

Device: conventional localization marker needle