Super-Resolution Ultrasound of the Brain in 3D
ConditionCerebral Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Transtemporal ultrasound with contrast product (Sonovue)
Procedure/SurgeryDuring 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Cohort groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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 caliber of visible vessels (mm)
Time frame
Day 12
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)
Time frame
Day 13
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)
Time frame
Day 14
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
Time frame
Day 1Secondary outcomes
1
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
vessels caliber (mm)
Time frame
Day 12
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
visible vessels (number)
Time frame
Day 13
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)
stroke size (mm3)
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Centre National de la Recherche Scientifique, France
Collaborator
Source ClinicalTrials.gov