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Идёт набор NCT07155954

Value of Super-resolution Ultrasonography in Differentiating Benign and Malignant Lymph Nodes

— Наблюдательное Lymphadenopathy Lymphnode Metastasis Lymphoma Lymphatic Tuberculosis

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: SRUS imaging of the lymph nodes before surgery or biopsy.
Кому может быть актуально
Состояния в реестре: Lymphadenopathy, Lymphnode Metastasis, Lymphoma, Lymphatic Tuberculosis. Базовые параметры: от 18 лет · Все.
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

Value of Super-resolution Ultrasound Microvascular Imaging in Distinguishing Benign and Malignant Superficial Lymph Nodes: a Prospective Multi-center Study

Обзор

Lymph nodes are one of the most important components of the human immune system, and superficial lymph node enlargement lacks specificity. Ultrasound examination has been widely used in the diagnosis of lymph node lesions and is of great significance in distinguishing between benign and malignant. However, the two-dimensional and Doppler ultrasound features of different types of lymph node lesions overlap and intersect, and the blood flow perfusion information of lymph nodes can provide more information for differentiation. At present, the widely used contrast-enhanced ultrasound is easier to evaluate blood flow perfusion and can display small blood vessels smaller than 100 microns. The diagnostic accuracy of cervical lymph nodes using contrast-enhanced ultrasound is 80-90%. However, current contrast-enhanced ultrasound is limited by physical diffraction, with a resolution ranging from sub-millimeter to millimeter. This limitation hinders the visualization of small blood vessels or microcirculation by ultrasound, and parameters such as vascular size, spatial vascular pattern, and velocity of microcirculation are crucial for disease diagnosis and prognosis evaluation. Super resolution ultrasound (SRUS) is a new blood flow imaging technique. By tracking the movement trajectory of micro-bubbles instead of imaging the micro-bubbles themselves, the ultrasound diffraction limit can be exceeded to improve the sensitivity and image resolution of blood flow. Thus the study aim to evaluate the feasibility of SRUS technology in distinguishing between benign and malignant lymph nodes, and compare the differences in blood flow distribution and perfusion index between benign and malignant lymph nodes under SRUS imaging.

Подробное описание

The study aim to evaluate the feasibility of SRUS technology in distinguishing between benign and malignant lymph nodes, and compare the differences in blood flow distribution, perfusion index, CEUS parameters, blood supply mode between benign and malignant lymph nodes under SRUS imaging.

Вмешательства

  • Диагностический тест SRUS imaging of the lymph nodes before surgery or biopsy
    Ultrasound contrast agent (Sonovue/Sonazoid) is administered to the patients through a peripheral vein. When the micro-bubbles enter the lymph nodes, super-resolution ultrasonography imaging will initiate immediately, to capture the trajectory of the micro-bubbles, thus construct a map of the microvascular distribution.

Первичные конечные точки

  • benign or malignant pathology results from biopsy or surgery [Срок оценки: within 1 month after SRUS imaging]
Вторичные конечные точки (5)
  • The expression level of various immuno-histochemical indicators of lymph nodes [Срок оценки: within 2 months after SRUS imaging]
  • Microvascular Quantitative Indices between benign and malignant lymph nodes by SRUS [Срок оценки: within 2 months after the SRUS]
  • Microvascular Quantitative Indices between lymph node metastasis and lymphoma [Срок оценки: within 2 months after the SRUS imaging]
  • Blood supply mode of CEUS between benign and malignant lymph nodes [Срок оценки: within 2 months after the SRUS imaging]
  • Quantitative analysis parameters of CEUS between benign and malignant lymph nodes [Срок оценки: within 2 months after SRUS imaging]

Критерии участия

Критерии включения

  • (1)suggested abnormal lymph nodes indicated by ultrasonography; (2) Patients scheduled for lymph nodes puncture or fine needle aspiration or surgery; (3) Age greater than or equal to 18 years old.

Критерии исключения

  • (1) Pregnant and lactating women; (2)pathological results not indicating benign or malignant lymph nodes; (3) history of chemotherapy or radiotherapy ; (4) History of allergies to eggs, milk, and ultrasound contrast agents; (5) Patients with acute coronary syndrome, severe pulmonary hypertension, or acute respiratory distress syndrome.

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
  • Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT07155954 · M2024853

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗