Comparison of Ultrasound Cerebral Perfusion Imaging With Routine Perfusion CT

NCT07324421 | Recruiting

• 1 other identifier: 2025-A00023-46
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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; Cerebral Ischemia; Brain Injuries, Vascular; Neurological Complication

Outcome Measures

Primary Outcomes (1)

• Performance of SYLVER system by determining the concordance with CT for principal vascular network localization and perfusion parameters.

  On all the patients recruited during the study, assess the performance of the SYLVER system by determining the concordance between the cerebral perfusion parameters from the evaluated medical device and those provided by CTP.

  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.

Secondary Outcomes (7)

• Calibration Function Between SYLVER Perfusion Metrics and CTP Measurements

  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

  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

  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

  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

  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.

Study Arms (1)

Patients admitted to the ICU or CCU

EXPERIMENTAL

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

Device: Ultrasound contrast agent (Contrast-enhanced ultrasound)

Interventions

Ultrasound contrast agent (Contrast-enhanced ultrasound) 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).

Patients admitted to the ICU or CCU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Resolve Stroke: lead

Study Sites (1)

Centre Hospitalo-Universitaire Gui de Chauliac

Montpellier, Herault, 34000, France

RECRUITING

MeSH Terms

Conditions

Brain Ischemia; Cerebrovascular Trauma

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Vivien Szabo, MD, PHD

CONTACT

+33467336733; v-szabo@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: January 7, 2026
• Study Start: October 25, 2025
• Primary Completion (Estimated): June 4, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)