3D ultrasound imaging of the brain for stroke detection
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.
NA · Assistance Publique - Hôpitaux de Paris · NCT06133179
This study is testing a new 3D ultrasound method to see if it can help detect strokes in people who have recently had one.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT06133179 on ClinicalTrials.gov |
What this trial studies
This proof of concept study aims to visualize the middle cerebral artery and its branches using 3D transtemporal ultrasound imaging to assess the presence of ischemic stroke. Twenty participants who have suffered a stroke will undergo a specialized ultrasound examination within a week of their stroke. The data collected will be analyzed by a medical imaging laboratory to determine the accuracy of this method compared to standard imaging techniques like CT and MRI.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over who have experienced an ischemic stroke in the deep territory of the middle cerebral artery within the past week.
Not a fit: Patients with strokes in the contralateral middle cerebral artery territory or those with contraindications to the ultrasound procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive and accurate method for diagnosing ischemic strokes.
How similar studies have performed: While this approach is innovative, it is not widely tested, making it a novel exploration in stroke imaging.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris, Île-de-France Region
- Hôpital Bichat — Paris, Île-de-France Region, France (RECRUITING)
Study contacts
- Study coordinator: Elena MESEGUER, Dr
- Email: elena.meseguer@aphp.fr
- Phone: 01.40.25.70.33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Stroke