Evaluation of the Interest of Ultra-high Frequency Doppler Ultrasound (UFDU) in the Surgical Management of Patients Operated in an Awake Condition for a Cerebral Tumor

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

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-25

Study Completion Date

2018-04-25

Brief Summary

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In brain tumor surgery we are confronted mainly with two types of difficulties: (i) the identification of the tumor and its limitations in relation to the healthy brain; (ii) the identification of functional cerebral regions, ie implicated in neurological function (motor skills, sensitivity, language, vision, cognition, etc.). The reference method currently used to improve the quality of resection of brain tumors while minimizing neurological risk for patients is so called "wakeful" surgery with direct electrical stimulation (DES) of the brain. The investigators routinely use ultrasound to localize the tumor within the brain, but to date there is no pre- or intra-operative imaging tool to reliably identify tumors and functional brain regions. There is therefore a need for innovative imaging in this field.

For this reason, the investigators propose to evaluate the interest of a new High Frequence Ultrasound Doppler (HFUD) (VEVO ®, Visualsonics, Toronto, Canada) in the surgical management of patients operated in an awake condition for a brain tumor. The ultra high frequency allows to reach a spatial resolution of 30 μm, 5 to 10 times better than MRI and conventional ultrasound. The Doppler mode allows the detection of microvascular flows of speeds less than 1 mm / second. The safety of this device is demonstrated and validated by CE marking (December 2015).

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Detailed Description

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Conditions

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Cerebral Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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HFUD utilisation

Group Type EXPERIMENTAL

High Frequence Ultrasound Doppler (HFUD) utilisation

Intervention Type OTHER

Utilisation of HFUD will be done during on patients during an operation in waking condition. This procedure extends the usual procedure from 15 to 20 minutes.

Interventions

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High Frequence Ultrasound Doppler (HFUD) utilisation

Utilisation of HFUD will be done during on patients during an operation in waking condition. This procedure extends the usual procedure from 15 to 20 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* operated patient of a cerebral tumor in an awake condition
* age\> 18 years
* neurological condition allowing the realization of the tests in the operating room