Clinical trial NCT02656407: Intraoperative Functional Ultrasound
Official title: Doppler Ultrasonore Ultrasensible Peropératoire du Cerveau - Vers Une Aide Temps Reel à la Cartographie Corticale Fonctionnelle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Brain Lesion
Keywords: Functional Ultrasound
Intraoperative
Brain
Doppler
Ultrasound
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2016-01-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Activation maps through intraoperative ultrasensitive Doppler compared to gold standards cortical simulation mapping and functional MRI
timeFrame: During the surgery
Secondary outcomes:
measure: Sensitivity test of the new Doppler mode
timeFrame: During surgery
measure: In depth micro vessel localization
timeFrame: During surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpetriere Hospital
state: Ile De France
Study officials:
affiliation: Neurosurgery department
name: Dorian Chauvet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demene C, Deffieux T, Pernot M, Osmanski BF, Biran V, Gennisson JL, Sieu LA, Bergel A, Franqui S, Correas JM, Cohen I, Baud O, Tanter M. Spatiotemporal Clutter Filtering of Ultrafast Ultrasound Data Highly Increases Doppler and fUltrasound Sensitivity. IEEE Trans Med Imaging. 2015 Nov;34(11):2271-85. doi: 10.1109/TMI.2015.2428634. Epub 2015 Apr 30.