Super-Resolution Ultrasound of the Brain in 3D (ESRC3D)

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).

Study Overview

• Status: Recruiting
• Conditions: Cerebral Stroke
• Intervention / Treatment: Procedure: Transtemporal ultrasound with contrast product (Sonovue)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena MESEGUER, Dr; Phone Number: +33 01.40.25.70.33; Email: elena.meseguer@aphp.fr
• Study Contact Backup: Name: Marine CAMUS, Mrs; Phone Number: +33 01.40.27.40.76; Email: marine.camus2@aphp.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75018
      • Recruiting
      • Hopital Bichat
      • Contact: Elena Dr MESEGUER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort group; Routine care + transtemporal ultrasound examination with contract product during hospitalization	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)	vessels caliber (mm)	Day 1
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)	visible vessels (number)	Day 1
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)	stroke size (mm3)	Day 1

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Centre National de la Recherche Scientifique, France

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 27, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: APHP230511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No