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

NCT03179176 | Completed

• 1 other identifier: 17-PP-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cerebral Tumor

Outcome Measures

Primary Outcomes (1)

• Diameter of the sulcus blood vessels

  before resection of the tumor

Study Arms (1)

HFUD utilisation

EXPERIMENTAL

Other: High Frequence Ultrasound Doppler (HFUD) utilisation

Interventions

High Frequence Ultrasound Doppler (HFUD) utilisation 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.

HFUD utilisation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• not indicated for "awake" surgery
• refusal of participation of the patient
• pregnant or nursing women

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

Related Publications (1)

• Almairac F, Fontaine D, Demarcy T, Delingette H, Beuil S, Raffaelli C. Motor cortex neurovascular coupling: inputs from ultra-high-frequency ultrasound imaging in humans. J Neurosurg. 2018 Nov 9;131(5):1632-1638. doi: 10.3171/2018.5.JNS18754. Print 2019 Nov 1.

  PMID: 30497179 DERIVED

Study Officials

• Fabien ALMAIRAC, MD

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 7, 2017
• Study Start: April 25, 2017
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

FR (1)