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Recruiting NCT06133179

Super-Resolution Ultrasound of the Brain in 3D

No phase Interventional Cerebral Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transtemporal ultrasound with contrast product (Sonovue).
Who it may be relevant to
Registry conditions: Cerebral Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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).

Interventions

  • 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

Primary outcome measures

  • 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Day 1]
Secondary outcome measures (3)
  • Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI) [Time frame: Day 1]
  • Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI) [Time frame: Day 1]
  • Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI) [Time frame: Day 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Hôpital Bichat — Paris

Identifiers

NCT: NCT06133179 · APHP230511

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗