Super-Resolution Ultrasound of the Brain in 3D

Cerebral Stroke Clinical Trial

— ESRC3D  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133179
• Other study ID #: APHP230511
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2024
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Elena MESEGUER, Dr
• Phone: 01.40.25.70.33
• Email: elena.meseguer[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Hôpital Bichat	Paris	Ile De France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Centre National de la Recherche Scientifique, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Day 1
Primary	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)	Day 1
Primary	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)	Day 1
Primary	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	Day 1
Primary	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	Day 1
Secondary	Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)	vessels caliber (mm)	Day 1
Secondary	Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)	visible vessels (number)	Day 1
Secondary	Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)	stroke size (mm3)	Day 1