Super-Resolution Ultrasound of the Brain in 3D

NCT ID: NCT06133179

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-22

Study Completion Date

2025-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Cerebral Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cohort group

Routine care + transtemporal ultrasound examination with contract product during hospitalization

Group Type EXPERIMENTAL

Transtemporal ultrasound with contrast product (Sonovue)

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Bichat

Paris, Île-de-France Region, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Elena MESEGUER, Dr

Role: CONTACT

01.40.25.70.33 ext. +33

Marine CAMUS, Mrs

Role: CONTACT

01.40.27.40.76 ext. +33

Facility Contacts

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Elena Dr MESEGUER

Role: primary

Other Identifiers

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APHP230511

Identifier Type: -

Identifier Source: org_study_id

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