Super-Resolution Ultrasound of the Brain in 3D

NCT06133179 | Recruiting

• 1 other identifier: APHP230511
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cerebral Stroke

Outcome Measures

Primary Outcomes (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

  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 Outcomes (3)

• Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)

  Day 1

• Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)

  Day 1

• Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)

  Day 1

Study Arms (1)

Cohort group

EXPERIMENTAL

Routine care + transtemporal ultrasound examination with contract product during hospitalization

Procedure: Transtemporal ultrasound with contrast product (Sonovue)

Interventions

Transtemporal ultrasound with contrast product (Sonovue) PROCEDURE

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

Cohort group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Hôpital Bichat

Paris, Île-de-France Region, 75018, France

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

contrast agent BR1

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Elena MESEGUER, Dr

CONTACT

01.40.25.70.33; elena.meseguer@aphp.fr

Marine CAMUS, Mrs

CONTACT

01.40.27.40.76; marine.camus2@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof of concept, exploratory, single group, non-comparative, uncontrolled study

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 15, 2023
• Study Start: March 22, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)