Breast Ductal Carcinoma In Situ, Mammary Tumor, Nipple Discharge
Conditions
Keywords
micro lesions, breast duct, fluorescent ductal needle, localization needle, controllable detachment
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.
Interventions
novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating
conventional localization marker needle, without any coating
Sponsors
The Fourth Affiliated Hospital of China Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological assessment concordance rates | From enrollment to the end of treatment at 6 weeks | 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. |
Countries
China
Contacts
CONTACTJian Wen, MD
PRINCIPAL_INVESTIGATORJian Wen, MD
The Fourth Affiliated Hospital of China Medical University
Outcome results
None listed