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Идёт набор NCT05484245

Sonography-guided Resection of Brain Mass Lesions

Без фазы С лечением Tumor, Brain Arteriovenous Malformations Cavernoma Intracerebral Hematoma

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: Sonography.
Кому может быть актуально
Состояния в реестре: Tumor, Brain, Arteriovenous Malformations, Cavernoma, Intracerebral Hematoma. Базовые параметры: 18 лет — 100 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
Россия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Sonography-guided Resection of Brain Mass Lesions: a Prospective, Single Arm Clinical Trial

Обзор

Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.

Подробное описание

Intraoperative sonography is usially used in neurooncology to detect brain tumors and exclude their remnants. A few studies describe it's usage while removing hematomas or vascular malformations. Ultrasound is the only method allowing to observe brain tissue in real time. It is chip and doesn't violate surgical workflow. Main disadvantages of sonography are lengthy learning curve and poorer image quality compared to magnetic resonance imaging. Novel acoustic coupling fluid, contrast-enhanced ultrasound and elastography expanded it's effectiveness. Meanwhile problems of locating of isoechogenic lesions with poor margins and elimination of artefacts are steel actual.

Objective of the study is to determine possibilities of intraoperative sonography in detecting of various brain mass lesions, assessing extent of their resection and define indications to use ultrasound-guided needle or ultrasound wire-guided port.

A surgeon will intraoperatively locate mass lesion and assess extent of it's resection with sonography. Ultrasound scanning will be performed through the same surgical approach or at a distance through enlarged craniotomy, periodically or permanently. To facilitate approach to subcortical and deep small mass lesions ultrasound-guided needle or ultrasound wire-guided port will be used.

Вмешательства

  • Устройство Sonography
    Surgeon detects brain mass lesion and assesses extent of it's resection with sonography

Первичные конечные точки

  • Ultrasound features of various brain mass lesions in Mair scale (in grades) [Срок оценки: Intraoperatively]
Вторичные конечные точки (12)
  • Sensitivity of intraoperative sonography to detect mass lesion compared to preoperative magnetic resonance imaging or computed tomography (in percents) [Срок оценки: Intraoperatively]
  • Sensitivity of intraoperative sonography to detect residual mass lesion compared to postoperative magnetic resonance imaging or computed tomography (in percents) [Срок оценки: Within 48 hours after surgery]
  • Specificity of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents) [Срок оценки: Within 48 hours after surgery]
  • Positive predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents) [Срок оценки: Within 48 hours after surgery]
  • Negative predictive value of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents) [Срок оценки: Within 48 hours after surgery]
  • Accuracy of intraoperative sonography to detect residual mass lesions compared to postoperative magnetic resonance imaging or computed tomography (in percents) [Срок оценки: Within 48 hours after surgery]
  • Duration of mass lesion removal (in minutes) [Срок оценки: Intraoperatively]
  • Extent of resection (in percents) [Срок оценки: Within 48 hours after surgery]
  • Differentiation between artefacts and residual lesion (Yes or No) [Срок оценки: Intraoperatively]
  • Duration of approach to mass lesion using ultrasound-guided needle or ultrasound wire-guided port (in minutes) [Срок оценки: Intraoperatively]
  • Karnofsky performance status (in percents) [Срок оценки: Within 10 days after surgery]
  • Cerebral complications [Срок оценки: From admission to intensive care unit after surgery till hospital discharge, up to 365 days]

Критерии участия

Критерии включения

  • all intracranial tumors
  • cavernomas
  • arteriovenous malformations
  • spontaneous (non-traumatic) intracerebral hemorrhages
  • traumatic intracerebral hemorrhages
  • supratentorial localization
  • newly diagnosed
  • age 18-100 years
  • stable hemodynamics

Критерии исключения

  • rapid cerebral dislocation
  • previously performed brain radiotherapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Россия · 1 центр
  • Sklifosovsky Institute of Emergency Care — Moscow

Идентификаторы

NCT: NCT05484245 · 9g

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗