A Novel Fluorescent Ductal Needle for Localization and Sampling of Micro Lesions in Breast Ducts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: novel fluorescent localization marker needle, conventional localization marker needle.
- Who it may be relevant to
- Registry conditions: Mammary Tumor, Nipple Discharge, Breast Ductal Carcinoma In Situ. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Novel Fluorescent Ductal Needle With Controllable Detachment for Realtime Localization and Sampling of Micro Lesions in Breast Ducts: a Prospective, Multicenter Study
Overview
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
- Device novel fluorescent localization marker needle
novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating - Device conventional localization marker needle
conventional localization marker needle, without any coating
Primary outcome measures
- pathological assessment concordance rates [Time frame: From enrollment to the end of treatment at 6 weeks]
Eligibility criteria
Inclusion criteria
- Female patients aged 18-75 years.
- Patients scheduled to undergo duct excision surgery.
- Patients who are capable of providing written informed consent and adhering to the study protocols.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- The Fourth Affiliated Hospital of China Medical University — Shenyang
Identifiers
NCT: NCT07339306 · FourthAHChinaMU-PMS