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Идёт набор NCT07339306

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

Без фазы С лечением Mammary Tumor Nipple Discharge Breast Ductal Carcinoma In Situ

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: novel fluorescent localization marker needle, conventional localization marker needle.
Кому может быть актуально
Состояния в реестре: Mammary Tumor, Nipple Discharge, Breast Ductal Carcinoma In Situ. Базовые параметры: 18 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Novel Fluorescent Ductal Needle With Controllable Detachment for Realtime Localization and Sampling of Micro Lesions in Breast Ducts: a Prospective, Multicenter Study

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство novel fluorescent localization marker needle
    novel fluorescent localization needle, which features a controllable shedding quantum dot chiral nanofluorescent coating
  • Устройство conventional localization marker needle
    conventional localization marker needle, without any coating

Первичные конечные точки

  • pathological assessment concordance rates [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Китай · 1 центр
  • The Fourth Affiliated Hospital of China Medical University — Шэньян

Идентификаторы

NCT: NCT07339306 · FourthAHChinaMU-PMS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗