Intraoperative Functional Ultrasound

Not Applicable

Completed

• Conditions: Brain Lesion; Brain Tumor
• Interventions: Device: Ultrasound device

• Registration Number: NCT02656407
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-15
• Study Start: 2016-02-11
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasensitive Doppler	Ultrasound device	Intraoperative ultrasensitive Doppler acquisitions by using an ultrasound device for functional area detection

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Pitié Salpetriere Hospital; 🇫🇷 Paris, Ile De France, France