Brain PERfusion Evaluation by Contrast-Enhanced UltraSound

NCT05893407 | Recruiting

• 2 other identifiers: APHP2304892023-A00939-36
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to assess brain tissue perfusion by contrast-enhanced ultrasound perfusion imaging (PerCEUS) in acute brain injuries. More precisely, it aims :

• to evaluate the heterogeneity of brain perfusion and thus diagnose brain tissue hypoperfusion with contrast-enhanced ultrasound.
• to correlate contrast-enhanced ultrasound with perfusion measurements by usual multimodal monitoring.

Conditions

Cerebral Hemorrhage; Subarachnoid Hemorrhage; Ischemic Stroke; Cerebrovascular Circulation; Perfusion

Keywords

Brain perfusion; Cerebral blood flow; Diagnostic imaging; Ultrasonography Doppler; Doppler ultrasound; Transcranial Doppler; Contrast enhanced ultrasound; Contrast-enhanced ultrasonography; Contrast ultrasound; Ultrasound perfusion imaging; Ultrasound contrast agent; Intra-cranial pressure; Intracerebral hematoma; Neurocritical care

Outcome Measures

Primary Outcomes (2)

• Evaluation of the heterogeneity of brain perfusion by time-to-peak (TPI) measurement

  Comparison between time-to-peak (TPI) intensities measured in ROIs in each area by PerCEUS

  30 minutes after PerCEUS

• Evaluation of the heterogeneity of brain perfusion by peak-intensities (PI) measurement

  Comparison between peak-intensities (PI) measured in ROIs in each area by PerCEUS

  30 minutes after PerCEUS

Secondary Outcomes (4)

• Correlation between PerCEUS parameters and cerebral perfusion as assessed by ICP and MAP

  30 minutes after PerCEUS

• Correlation between PerCEUS parameters and cerebral perfusion as assessed by TCD

  30 minutes after PerCEUS

• Correlation between PerCEUS parameters and cerebral perfusion as assessed by NIRS

  30 minutes after PerCEUS

• Correlation between PerCEUS parameters and cerebral perfusion as assessed by SjvO2

  30 minutes after PerCEUS

Study Arms (1)

Patients with acute brain injuries when a contrast ultrasound imaging is requested by the physician

Contrast-enhanced ultrasound perfusion imaging (PerCEUS)

Diagnostic Test: Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging

Interventions

Measuring contrast-enhanced ultrasound perfusion with phase inversion harmonic imaging DIAGNOSTIC_TEST

Contrast-enhanced ultrasound perfusion imaging (PerCEUS) will be performed by a dedicated study team. The transcranial color duplex sonography will be performed with a 1-5 MHz dynamic sector array (S5-1) from a Philips Epiq 7 ultrasound machine (Philips Healthcare, Andover, MA). The field-of-view will be set to an imaging depth of 150 mm in a sector angle of 90°. The imaging plane will be then tilted to the diencephalic, in which the frontal horns of the side ventricles and the third ventricle serve as landmarks and where the anterior and posterior middle cerebral artery (MCA) territory and the basal ganglia (BG) as region of interest could be identified without artefacts from major vessels. High mechanical index bolus imaging will be performed from the sanest side of the head. Data acquisition of 45 seconds will be recorded immediately after the beginning of the contrast ultrasound imaging, using a mechanical index (MI) setting of 1.1 and a frame rate of 33 Hz.

Patients with acute brain injuries when a contrast ultrasound imaging is requested by the physician

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in neurosurgical intensive care in Lariboisière Hospital, Paris, with acute brain injuries

You may qualify if:

• Age ≥18
• Intensive care unit admission for acute brain injury
• Proven acute brain injury by CT and/or MRI
• Requiring a contrast ultrasound imaging
• Informed consent of patient or relative

You may not qualify if:

• Pregnancy
• Not sufficient temporal window
• Contraindications to Sonovue ® : acute coronary syndromes, severe ischemic heart disease (requiring revascularization), pulmonary arterial hypertension \> 90 mmHg, right-left shunt, ARDS, dobutamine's use, known allergy or adverse reaction to Sonovue®
• Patient on State Medical Assistance

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Lariboisière Hospital

Paris, 75010, France

RECRUITING

Related Publications (5)

• Eyding J, Krogias C, Wilkening W, Postert T. Detection of cerebral perfusion abnormalities in acute stroke using phase inversion harmonic imaging (PIHI): preliminary results. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):926-9. doi: 10.1136/jnnp.2003.026195.

  PMID: 15146019 BACKGROUND

• Eyding J, Fung C, Niesen WD, Krogias C. Twenty Years of Cerebral Ultrasound Perfusion Imaging-Is the Best yet to Come? J Clin Med. 2020 Mar 17;9(3):816. doi: 10.3390/jcm9030816.

  PMID: 32192077 BACKGROUND

• Vinke EJ, Kortenbout AJ, Eyding J, Slump CH, van der Hoeven JG, de Korte CL, Hoedemaekers CWE. Potential of Contrast-Enhanced Ultrasound as a Bedside Monitoring Technique in Cerebral Perfusion: a Systematic Review. Ultrasound Med Biol. 2017 Dec;43(12):2751-2757. doi: 10.1016/j.ultrasmedbio.2017.08.935. Epub 2017 Sep 28.

  PMID: 28964614 BACKGROUND

• Fung C, Heiland DH, Reitmeir R, Niesen WD, Raabe A, Eyding J, Schnell O, Rolz R, Z Graggen WJ, Beck J. Ultrasound Perfusion Imaging for the Detection of Cerebral Hypoperfusion After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2022 Aug;37(1):149-159. doi: 10.1007/s12028-022-01460-z. Epub 2022 Feb 24.

  PMID: 35211837 BACKGROUND

• Bilotta F, Robba C, Santoro A, Delfini R, Rosa G, Agati L. Contrast-Enhanced Ultrasound Imaging in Detection of Changes in Cerebral Perfusion. Ultrasound Med Biol. 2016 Nov;42(11):2708-2716. doi: 10.1016/j.ultrasmedbio.2016.06.007. Epub 2016 Jul 27.

  PMID: 27475927 BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage; Subarachnoid Hemorrhage; Ischemic Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Study Officials

• Romain BARTHELEMY, MD

  AP-HP Lariboisière Hospital, Department of Anaesthesia and Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain BARTHELEMY, MD

CONTACT

+33 (0)1 49 95 85 15; romain.barthelemy@aphp.fr

Benjamin Glenn CHOUSTERMAN, MD PhD

CONTACT

+33 (0)1 49 95 85 18; benjamin.chousterman@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 7, 2023
• Study Start: July 21, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)