Comparison of Ultrasound Cerebral Perfusion Imaging With Routine Perfusion CT

Официальное название

Prospective Monocentric Study Comparing Cerebral Perfusion Parameters From an ULtrasonic Imaging System With Measures Provided by Clinical Routine Perfusion CT

Обзор

The primary goal of neurocritical care is to prevent secondary brain injury, which worsens neurological outcomes. Because clinical monitoring is often insufficient due to the patient's condition and medical treatments, multimodal monitoring using biophysical, electrophysiological, and imaging data is essential. In patients with subarachnoid hemorrhage (SAH), the most frequent and severe complication is delayed cerebral ischemia, often linked to arterial vasospasm and potentially leading to infarction. Early diagnosis combines transcranial Doppler (TCD), sensitive to vasospasm, with perfusion CT (CTP), which measures cerebral perfusion; this approach guides therapy and improves prognosis. Ultrasound, especially when enhanced with contrast agents (CEUS), allows non-invasive, bedside, repeated visualization of cerebral blood flow and perfusion-even through the skull. Agents like SonoVue® help quantify perfusion using time-intensity curves. The study aims to assess whether cerebral perfusion measurements from the SYLVER device are equivalent to those from CTP in ICU or CCU patients.

Вмешательства

• Устройство Ultrasound contrast agent (Contrast-enhanced ultrasound)
  The V0 (screening) visit occurs during ICU/CCU hospitalization, with routine clinical exam, eligibility check, and informed consent from the patient or a relative. Assessments include demographics, medical history, clinical exam, treatments, cerebral perfusion by CTP, anatomy by CTA, SYLVER perfusion/anatomy, TCD velocities, and AE/device deficiency recording. V0 lasts \~30 min. V1 (Day 1 or possibly Day 0 in urgent cases) includes clinical exam, TCD, CTP/CTA, and SYLVER use (\~30 min extra; tot

Первичные конечные точки

• Performance of SYLVER system by determining the concordance with CT for principal vascular network localization and perfusion parameters. [Срок оценки: The primary outcome will be measured by gathering Perfusion CT and study device's information (anatomical and perfusion mapping) at each visit in which the patient can be enrolled, from V0 to V5 (maximum) and for 21 days inclusion maximum.]

Вторичные конечные точки (7)

• Calibration Function Between SYLVER Perfusion Metrics and CTP Measurements [Срок оценки: From Visit V0 to Visit V5 (maximum 5 visits with SYLVER scan) within 21 days after inclusion.]
• Correlation Between SYLVER-Reference Parameters Mismatch and Clinical and Technical Variables [Срок оценки: From Visit V0 to Visit V5 (maximum 5 visits including SYLVER scan) within 21 days after inclusion.]
• Sensitivity and Specificity of SYLVER for Detecting Hypoperfusion Compared With CT Perfusion [Срок оценки: The outcome will be measured by gathering Perfusion CT and study device's information (anatomical and perfusion mapping) at each visit in which the patient can be enrolled, from V0 to V5 (maximum) and for 21 days inclusion maximum.]
• Agreement of Brain Vessel Morphological Reconstruction Between SYLVER and CT Angiography [Срок оценки: The outcome will be measured by gathering Perfusion CT and study device's information (anatomical and perfusion mapping) at each visit in which the patient can be enrolled, from V0 to V5 (maximum) and for 21 days inclusion maximum.]
• Difference in Cerebral Blood Flow Velocities Between SYLVER and Transcranial Doppler [Срок оценки: The outcome will be measured by gathering Perfusion CT and study device's information (anatomical and perfusion mapping) at each visit in which the patient can be enrolled, from V0 to V5 (maximum) and for 21 days inclusion maximum.]
• Total Diagnostic Care Cost per Patient With and Without Use of SYLVER [Срок оценки: The outcome will be measured by gathering Perfusion CT and study device's information (anatomical and perfusion mapping) at each visit in which the patient can be enrolled, from V0 to V5 (maximum) and for 21 days inclusion maximum.]
• Incidence of Adverse Events, Serious Adverse Events, and Device Deficiencies Related to SYLVER Use [Срок оценки: The outcome will be measured by gathering study device's information at each visit in which the patient can be enrolled, from V0 to V5 (maximum) and for 21 days inclusion maximum.]

Критерии участия

Критерии включения

• Patient ≥ 18 years old
• Patient Informed Consent, or from his/her relative if the patient is not conscious and able to consent
• Admission to ICU or CCU with indication to perform at least one CTP
• Affiliated with or benefiting from a social security scheme
• The subject's current clinical status, as assessed by medical history, physical examination, and/or relevant tests, indicates that they do not require immediate medical treatment or emergency care at the time of enrolment.

Критерии исключения

• Guardianship, curatorship or any deprivation of liberty by judicial or administrative decision
• Pregnant or breast-feeding women
• Known contra-indication or hypersensitivity to SonoVue® (to sulfur hexafluoride microbubbles or to one of its excipients such as polyethylene glycol (PEG))
• Right-to-left shunts
• Patients who have undergone craniectomy in the temporal region
• Patients with open wounds or recent scars in the temporal region
• Unstable hemodynamic or respiratory state contraindicating transportation to CTP scanner

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

Диагностика

Центры проведения

Франция · 1 центр

• Centre Hospitalo-Universitaire Gui de Chauliac — Montpellier

Идентификаторы

NCT: NCT07324421 · 2025-A00023-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗