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NCT Number: NCT06133179

Super-Resolution Ultrasound of the Brain in 3D

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Bichat

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

Location status: Recruiting

Location contact

Elena Dr MESEGUER

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

    Time frame: Day 1

    Measure of the caliber of visible vessels (mm)

  2. 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

    Measure of the number of visible vessels (number)

  3. 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

    Measure of the speed of the flows (mm/sec)

  4. 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

    Measure of the directionality of the flows

  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

    Time frame: Day 1

    Measure of the diffusion index

Secondary outcomes

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

    Time frame: Day 1

    vessels caliber (mm)

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

    Time frame: Day 1

    visible vessels (number)

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

    Time frame: Day 1

    stroke size (mm3)

Study contacts

Contact information is provided by the study sponsor or research team.

Elena MESEGUER, Dr

CONTACT

[email protected]

01.40.25.70.33 ext. +33

Marine CAMUS, Mrs

CONTACT

[email protected]

01.40.27.40.76 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Centre National de la Recherche Scientifique, France

Registry information

Official study 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.

Acronym: ESRC3D

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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