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Super-Resolution Ultrasound of the Brain in 3D

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.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06133179
Acronym
ESRC3D
Enrollment
20
Registered
2023-11-15
Start date
2024-03-22
Completion date
2025-02-28
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Stroke

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).

Interventions

PROCEDURETranstemporal 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

Sponsors

Centre National de la Recherche Scientifique, France
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforatorsDay 1Measure of the caliber of visible vessels (mm)

Secondary

MeasureTime frameDescription
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI)Day 1vessels caliber (mm)

Countries

France

Contacts

Primary ContactElena MESEGUER, Dr
elena.meseguer@aphp.fr01.40.25.70.33
Backup ContactMarine CAMUS, Mrs
marine.camus2@aphp.fr01.40.27.40.76

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026