Super-Resolution Ultrasound of the Brain in 3D (NCT06133179) | Clinical Trial Compass
RecruitingNot Applicable
Super-Resolution Ultrasound of the Brain in 3D
France20 participantsStarted 2024-03-22
Plain-language 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. 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: Day 1
2
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
Timeframe: Day 1
3
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
Timeframe: Day 1
4
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
Timeframe: Day 1
5
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