Intraoperative Functional Ultrasound (FUSIMAGINE)

Doppler Ultrasonore Ultrasensible Peropératoire du Cerveau - Vers Une Aide Temps Reel à la Cartographie Corticale Fonctionnelle

A wide spectrum of methods is used to image brain activation in vivo. It can be directly detected by neurons electrical activity imaging (cortical simulation mapping, calcium imaging, voltage sensitive dyes) or indirectly by imaging hemodynamic changes induced by the neurovascular coupling in the vessels surrounding the activated neurons (intrinsic optical imaging, photoacoustic imaging, positron emission tomography (PET), functional magnetic resonance imaging (fMRI)).

Ultrasound as the potential to complement these functional imaging techniques at low cost. Ultrasound imaging can do real-time in-depth imaging of brain. However, its use to imaging of major vessels has been limited until now due to its poor sensitivity. To overcome this limitation functional ultrasound (fUS) was developed in Institut Langevin since 2011. This technique enables high spatio-temporal resolution imaging of whole-brain microvasculature dynamics in response to brain activation without the need of contrast agent.

This fUS method relies on a new power Doppler imaging sequence sensitive enough to detect blood flow in most of cerebral vessels (arterioles, big venules and larger vessels). Repeating the acquisition of such ultrasensitive Doppler images over time enables to follow flow dynamics in such vessels modulated by local neuronal activity.

Applied to the rat brain, fUS was proved able to map brain activation at high spatiotemporal resolution and high signal to noise ratio. The aim of this study is now to apply fUS on human brain in intraoperative condition.

The main objective of this study is to find activation maps through intraoperative ultrasensitive Doppler compared to gold standard cortical simulation mapping and functional MRI.

Secondly the investigators want to test sensitivity of this new Doppler mode. fUS method will be used for different types of stimuli and intensity and the investigators will do some control acquisitions. Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler to prove that this new Doppler mode enhance micro vessel visualization.

Study Overview

• Status: Completed
• Conditions: Brain Tumor; Brain Lesion
• Intervention / Treatment: Device: Ultrasound device

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75013
      • Pitié Salpêtrière hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women, adults ( > 18 years old)
• Participants who have to undergo brain surgery, awake or under general anesthesia, for tumor or lesion resection (all types of tumors and lesions, cortical or subcortical), with programmed intraoperative ultrasound and cortical simulation mapping.
• Consent form signed by the patient after being informed (written and oral) of the research protocol.
• Patient affiliate to the social welfare system

Exclusion Criteria:

• Minors ( < 18 years old)
• Pregnant, parturient or breastfeeding women
• Protected persons, under guardianship, or under any administrative or legal right and liberty revocation procedure
• Patient without affiliation to the social welfare system

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasensitive Doppler; Intraoperative ultrasensitive Doppler acquisitions by using an ultrasound device for functional area detection	Device: Ultrasound device; Ultrasensitive Doppler acquisition obtained with the Aixplorer ultrasound device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Activation maps through intraoperative ultrasensitive Doppler compared to gold standards cortical simulation mapping and functional MRI	During the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity test of the new Doppler mode	fUS method will be tested for different types of stimuli and intensity and the investigators will do some control acquisitions.	During surgery
In depth micro vessel localization	Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler.	During surgery

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Dorian Chauvet, MD, Neurosurgery department

Publications and helpful links

General Publications

• Demene C, Deffieux T, Pernot M, Osmanski BF, Biran V, Gennisson JL, Sieu LA, Bergel A, Franqui S, Correas JM, Cohen I, Baud O, Tanter M. Spatiotemporal Clutter Filtering of Ultrafast Ultrasound Data Highly Increases Doppler and fUltrasound Sensitivity. IEEE Trans Med Imaging. 2015 Nov;34(11):2271-85. doi: 10.1109/TMI.2015.2428634. Epub 2015 Apr 30.
• Imbault M, Chauvet D, Gennisson JL, Capelle L, Tanter M. Intraoperative Functional Ultrasound Imaging of Human Brain Activity. Sci Rep. 2017 Aug 4;7(1):7304. doi: 10.1038/s41598-017-06474-8.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimated): January 15, 2016

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; Brain; Doppler; Intraoperative; Functional Ultrasound
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: C14-66; 2015-A00661-48 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO