Cerebral StrokeESRC3DNCT06133179
Super-Resolution Ultrasound of the Brain in 3D
A study testing Transtemporal ultrasound with contrast product (Sonovue) in people with Cerebral Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The goal of this proof of concept study is to determine if the visualization of the middle cerebral artery and its perforators, through 3D transtemporal ultrasound imaging, is possible thanks to an off-line analysis by 3D ultrasound localization microscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Stroke
- What is being tested?
- Transtemporal ultrasound with contrast product (Sonovue)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2024to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 aged 18 and over
- Hospitalized patient with ischemic stroke in the deep territory of the middle cerebral artery
- Patient with lesion observable on MRI
- Patient included between 24 hours and 7 days after the ischemic stroke
- Patient with a temporal window which allows soundproofing of the polygon of Willis and the middle cerebral artery
- Patient having signed free, informed and written consent
- Patient affiliated to a social security system (excluding AME)
Who cannot join
- Contralateral middle cerebral artery territory stroke or contralateral middle cerebral artery occlusion
- Patient with contraindication to Doppler ultrasound with contrast (right-left shunt, severe pulmonary arterial hypertension)
- Patient with hypersensitivity to the active princip of Sonovue (sulfur hexafluoride) or these excipients
- Patient with uncontrolled systemic hypertension
- Patient with respiratory distress syndrome
- Patient under guardianship or curatorship
Show all 9Show fewer
- Pregnant or breastfeeding patient (positive blood pregnancy test during hospitalization)
- Patient with damaged skin at the temporal level
- Patient having presented in the 7 days preceding inclusion an acute coronary syndrome or suffering from unstable ischemic heart disease
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Bichat
Paris, Île-de-France Region, 75018
Elena Dr MESEGUER
About this study
Official title: Pilot Study of the Characterization of Subacute Ischemic Cerebrovascular Accidents in the Region of the Middle Cerebral Artery by 3D Ultrasound Localization Microscopy (ULM) with a Research Ultrasound System and Non-marketed 2D Matrix Probe.
The goal of this proof of concept study is to determine if the visualization of the middle cerebral artery and its perforators, through 3D transtemporal ultrasound imaging, is possible thanks to an off-line analysis by 3D ultrasound localization microscopy. Visualization of these vessels would allow us to conclude on the presence, or absence, of an ischemic stroke in the region of the middle cerebral artery.
To answer the question asked, 20 participants who suffered a stroke will carry out a transtemporal ultrasound examination specifically for research in the 7 days following his stroke. The data obtained will be analyzed by the CNRS medical imaging laboratory, in order to characterize the presence of a stroke and to compare the data obtained with that of standard examinations (CT and MRI).
- Conditions
- Cerebral Stroke
- Being tested
- Transtemporal ultrasound with contrast product (Sonovue)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transtemporal ultrasound with contrast product (Sonovue)Procedure or surgery
During their hospitalization and in the 7 days following their stroke, all patients will perform a transtemporal ultrasound including the use of Sonovue contrast product.
The examination will last 1 hour and will be carried out on the opposite side of the stroke then on the side of the stroke
| Study group | Role | What they receive |
|---|---|---|
| Cohort group | Experimental | Routine care + transtemporal ultrasound examination with contract product during hospitalization Receives: Procedure: Transtemporal ultrasound with contrast product (Sonovue) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
Measure of the caliber of visible vessels (mm)
Measured: Day 1
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
Measure of the number of visible vessels (number)
Measured: Day 1
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
Measure of the speed of the flows (mm/sec)
Measured: Day 1
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
Measure of the directionality of the flows
Measured: Day 1
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
Measure of the diffusion index
Measured: Day 1
Secondary outcomes (3)
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
vessels caliber (mm)
Measured: Day 1
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
visible vessels (number)
Measured: Day 1
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
stroke size (mm3)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start22 Mar 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Model description
- Proof of concept, exploratory, single group, non-comparative, uncontrolled study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133179
- Sponsor's protocol ID
- APHP230511
- Acronym
- ESRC3D
- Status last verified
- Sep 2024
- First submitted
- 27 Oct 2023
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Characterization of Subacute Ischemic Cerebrovascular Accidents in the Region of the Middle Cerebral Artery by 3D Ultrasound Localization Microscopy (ULM) with a Research Ultrasound System and Non-marketed 2D Matrix Probe.
- ClinicalTrials.gov ID
- NCT06133179
- Acronym / sponsor ID
- ESRC3D / APHP230511
- Conditions
- Cerebral Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 15 Nov 2023 (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 goal of this proof of concept study is to determine if the visualization of the middle cerebral artery and its perforators, through 3D transtemporal ultrasound imaging, is possible thanks to an off-line analysis by 3D ultrasound localization microscopy. Visualization of these vessels would allow us to conclude on the presence, or absence, of an ischemic stroke in the region of the middle cerebral artery.
To answer the question asked, 20 participants who suffered a stroke will carry out a transtemporal ultrasound examination specifically for research in the 7 days following his stroke. The data obtained will be analyzed by the CNRS medical imaging laboratory, in order to characterize the presence of a stroke and to compare the data obtained with that of standard examinations (CT and MRI).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof of concept, exploratory, single group, non-comparative, uncontrolled study
| Arm | Type | Receives |
|---|---|---|
| Cohort group | Experimental | Procedure: Transtemporal ultrasound with contrast product (Sonovue)Routine care + transtemporal ultrasound examination with contract product during hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged 18 and over
- Hospitalized patient with ischemic stroke in the deep territory of the middle cerebral artery
- Patient with lesion observable on MRI
- Patient included between 24 hours and 7 days after the ischemic stroke
- Patient with a temporal window which allows soundproofing of the polygon of Willis and the middle cerebral artery
Key exclusion criteria (9 listed)
- Contralateral middle cerebral artery territory stroke or contralateral middle cerebral artery occlusion
- Patient with contraindication to Doppler ultrasound with contrast (right-left shunt, severe pulmonary arterial hypertension)
- Patient with hypersensitivity to the active princip of Sonovue (sulfur hexafluoride) or these excipients
- Patient with uncontrolled systemic hypertension
- Patient with respiratory distress syndrome
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 |
|---|---|---|
| Transtemporal ultrasound with contrast product (Sonovue)During their hospitalization and in the 7 days following their stroke, all patients will perform a transtemporal ultrasound including the use of Sonovue contrast product. The examination will last 1 hour and will be carried out on the opposite side of the stroke then on the side of the stroke | Procedure or surgery | Cohort group |
Primary outcome
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
Time frame: Day 1
Measure of the caliber of visible vessels (mm)
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
Time frame: Day 1
Measure of the number of visible vessels (number)
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
Time frame: Day 1
Measure of the speed of the flows (mm/sec)
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
Time frame: Day 1
Measure of the directionality of the flows
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators
Time frame: Day 1
Measure of the diffusion index
3 secondary outcomes
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
Time frame: Day 1
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
Time frame: Day 1
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transtemporal ultrasound with contrast product (Sonovue) in people with Cerebral Stroke, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena MESEGUER, Dr (01.40.25.70.33 ext. +33, elena.meseguer@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators (time frame: Day 1). The study lists 5 primary outcomes in all. 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 19 Sep 2024.