Neuro ICUSCULPTNCT07324421
Comparison of Ultrasound Cerebral Perfusion Imaging With Routine Perfusion CT
A study testing Ultrasound contrast agent (Contrast-enhanced ultrasound) in people with Neuro ICU and Sub Arachnoid Hemorrhage, run by Resolve Stroke at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuro ICU, Sub Arachnoid Hemorrhage, Neurological Complication
- What is being tested?
- Ultrasound contrast agent (Contrast-enhanced ultrasound)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2025to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalo-Universitaire Gui de Chauliac
Montpellier, Herault, 34000
Chiara Martinez, +33467335224, chiara.martinez@chu-montpellier.fr
About this study
Official title: Prospective Monocentric Study Comparing Cerebral Perfusion Parameters From an ULtrasonic Imaging System With Measures Provided by Clinical Routine Perfusion CT
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
- Being tested
- Ultrasound contrast agent (Contrast-enhanced ultrasound)
- Medical subject headings
- Brain Ischemia, Cerebrovascular Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to the ICU or CCU | Experimental | Indication for at least one CTP to assess the risk of cerebral hypoperfusion. Receives: Device: Ultrasound contrast agent (Contrast-enhanced ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Mathematical calibration function describing the relationship between perfusion parameters measured by the SYLVER device and corresponding perfusion parameters measured by CT perfusion (CTP).
For each paired assessment (SYLVER + CTP), the following will be derived and reported at the subject level and/or aggregated level (as applicable):
- Estimated functional form of the calibration model (e.g., linear or non-linear relationship between SYLVER and CTP perfusion parameters). ii) Estimated calibration parameters of the model (e.g., slope, intercept, and other model coefficients linking SYLVER values to CTP values). iii) Goodness-of-fit metrics for the calibration model (e.g., correlation coefficients, error metrics) if pre-specified in the analysis plan. iv) Calibration parameters and model characteristics will be obtained from all available paired SYLVER and CTP measurements collected between V0 and V5.
Measured: 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
Mismatch between parameters measured by SYLVER and reference modalities, and its correlation with routine clinical variables. Parameters mismatch includes: (1) Time to Peak (TTP, seconds) SYLVER vs CT perfusion; (2) systolic and diastolic cerebral blood flow (cm/s) SYLVER vs transcranial Doppler; (3) anatomical visualization of brain vessels (vessel visualization score / agreement) SYLVER vs CT angiography; (4) hypoperfusion zone identification (presence, number, and/or volume of hypoperfused areas) SYLVER vs CT perfusion. Correlated variables include heart rate (bpm), blood pressure (mmHg), medication use, Glasgow Coma Scale score, neurological deficits. Correlation coefficients (dimensionless) will be reported.
Measured: 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
Concordance of areas reported hypoperfused or healthy, with the volume analyzed by SYLVER superimposed on the equivalent volume sample given by CTP
Measured: 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
Concordance of major cerebral morphological structures visualization assessed by an investigator, or by a qualitative assessment according to the morphological atlas for optimized parameter analysis
Measured: 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
Concordance of Doppler velocities in the Middle Cerebral Artery (MCA) provided by TCD acquisitions and the ones calculated from SYLVER parameters
Measured: 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
Total diagnostic care cost per patient with and without use of SYLVER as a diagnostic tool. The measure aggregates: (1) physician time, (2) nursing-assistant time, (3) radiology technician ("radio manipulator") time, and (4) radiological inteprentation time, each recorded in minutes and multiplied by the corresponding unit cost (cost per minute) to obtain a total personnel cost. Additional diagnostic resource costs directly related to the diagnostic strategy (e.g., imaging procedures) may be included according to a predefined cost schedule. The primary reported value will be the mean total diagnostic cost per patient (in local currency) in the SYLVER vs non-SYLVER pathways, and the difference between groups.
Measured: 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
Number and proportion of participants with at least one adverse event (AE), serious adverse event (SAE), or device deficiency occurring during use of the SYLVER device. AEs and SAEs will be collected from inclusion to the end of follow-up and classified by seriousness, severity, and relationship to the device or procedures, according to applicable regulatory definitions. Device deficiencies (e.g., malfunction, use error, or failure of the device to perform as intended) will be collected and summarized. Results will be reported as counts and percentages of participants with AEs, SAEs, and device deficiencies.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start25 Oct 2025
- Primary completion4 Oct 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resolve Stroke
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324421
- Sponsor's protocol ID
- 2025-A00023-46
- Acronym
- SCULPT
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monocentric Study Comparing Cerebral Perfusion Parameters From an ULtrasonic Imaging System With Measures Provided by Clinical Routine Perfusion CT
- ClinicalTrials.gov ID
- NCT07324421
- Acronym / sponsor ID
- SCULPT / 2025-A00023-46
- Conditions
- Neuro ICU, Sub Arachnoid Hemorrhage, Neurological Complication, Cerebral Ischemia, Brain Injuries, Vascular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Resolve StrokeIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- 4 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to the ICU or CCU | Experimental | Device: Ultrasound contrast agent (Contrast-enhanced ultrasound)Indication for at least one CTP to assess the risk of cerebral hypoperfusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Patients admitted to the ICU or CCU |
Primary outcome
Performance of SYLVER system by determining the concordance with CT for principal vascular network localization and perfusion parameters.
Time frame: 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.
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.
7 secondary outcomes
Calibration Function Between SYLVER Perfusion Metrics and CTP Measurements
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound contrast agent (Contrast-enhanced ultrasound) in people with Neuro ICU and Sub Arachnoid Hemorrhage, run by Resolve Stroke at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vivien Szabo, MD, PHD (+33467336733, v-szabo@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of SYLVER system by determining the concordance with CT for principal vascular network localization and perfusion parameters. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.