FUSIMAGINE: Intraoperative Functional Ultrasound

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Completed

CT.gov ID

NCT02656407

Collaborator

(none)

Enrollment

Location

Arm

23.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor Brain Lesion	Device: Ultrasound device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Feb 11, 2016

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Activation maps through intraoperative ultrasensitive Doppler compared to gold standards cortical simulation mapping and functional MRI [During the surgery]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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