Comparison of Ultrasound Cerebral Perfusion Imaging With Routine Perfusion CT

NCT ID: NCT07324421

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-25
• Study Completion Date: 2026-08-15

Brief Summary

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.

Conditions

Neuro ICU; Sub Arachnoid Hemorrhage; Neurological Complication; Cerebral Ischemia; Brain Injuries, Vascular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients admitted to the ICU or CCU

Indication for at least one CTP to assess the risk of cerebral hypoperfusion.

Group Type: EXPERIMENTAL

Ultrasound contrast agent (Contrast-enhanced ultrasound)

Intervention Type: DEVICE

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; total \~1h30). Imaging order is flexible but times are logged. V2-V5 occur if, by Day 21, ICU/CCU stay continues and care requires further CTP for suspected hypoperfusion (max once/day).

Interventions

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; total \~1h30). Imaging order is flexible but times are logged. V2-V5 occur if, by Day 21, ICU/CCU stay continues and care requires further CTP for suspected hypoperfusion (max once/day).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Resolve Stroke

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalo-Universitaire Gui de Chauliac

Montpellier, Herault, France

Site Status: RECRUITING

Countries

France

Central Contacts

Vivien Szabo, MD, PHD

Role: CONTACT

v-szabo@chu-montpellier.fr

+33467336733

Facility Contacts

Chiara Martinez

Role: primary

chiara.martinez@chu-montpellier.fr

+33467335224

Other Identifiers

2025-A00023-46

Identifier Type: -

Identifier Source: org_study_id