NCT03179176: EUHF_PRC

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

Completed NA Last updated 6 February 2024

What this trial tests

NA trial testing High Frequence Ultrasound Doppler (HFUD) utilisation in Cerebral Tumor in 4 participants. Completed in 25 April 2018.

Timeline

25 April 2017

Primary endpoint
25 April 2018

25 April 2018

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	4
Start date	25 April 2017
Primary completion	25 April 2018
Estimated completion	25 April 2018
Sites	1 location across France

Drugs / interventions tested

• High Frequence Ultrasound Doppler (HFUD) utilisation

Conditions studied

• Cerebral Tumor — all drugs for Cerebral Tumor →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

18 and older, any sex, with Cerebral Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Motor cortex neurovascular coupling: inputs from ultra-high-frequency ultrasound imaging in humans.
   Almairac F, Fontaine D, Demarcy T, Delingette H, et al · · 2019 · cited 4× · PMID 30497179 · DOI 10.3171/2018.5.jns18754