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Идёт набор NCT06994416

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

— Наблюдательное Mammary Tumor Nipple Discharge

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. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Novel Fluorescent Ductal Needle With Controllable Detachment for Real-time Localization and Sampling of High-risk Breast Micro Lesions: a Retrospective Study

Обзор

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.

Подробное описание

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.

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: Data analysis period: June 2025- December 2025]

Критерии участия

Критерии включения

  • Female patients aged 18-75 years.
  • Patients who have been diagnosed intraductal breast lesion by ductoscopy.
  • Patients who have undergone ductal excision.

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 with incomplete clinical data.
  • 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

Модель наблюдения
Когортное

Центры проведения

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

Публикации

  • Alshurbasi N, Cartlidge CWJ, Kohlhardt SR, Hadad SM. Predicting Patients Found to Have Malignancy at Nipple Duct Surgery. Breast Care (Basel). 2020 Oct;15(5):491-497. doi: 10.1159/000504528. Epub 2019 Dec 13. PMID 33223992

Идентификаторы

NCT: NCT06994416 · FourthAHChinaMU

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗