Intraoperative Functional Ultrasound (FUSIMAGINE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02656407|
Recruitment Status : Unknown
Verified February 2016 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Recruiting
First Posted : January 15, 2016
Last Update Posted : February 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor Brain Lesion||Device: Ultrasound device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Doppler Ultrasonore Ultrasensible Peropératoire du Cerveau - Vers Une Aide Temps Reel à la Cartographie Corticale Fonctionnelle|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
Experimental: Ultrasensitive Doppler
Intraoperative ultrasensitive Doppler acquisitions by using an ultrasound device for functional area detection
Device: Ultrasound device
Ultrasensitive Doppler acquisition obtained with the Aixplorer ultrasound device
- Activation maps through intraoperative ultrasensitive Doppler compared to gold standards cortical simulation mapping and functional MRI [ Time Frame: During the surgery ]
- Sensitivity test of the new Doppler mode [ Time Frame: During surgery ]fUS method will be tested for different types of stimuli and intensity and the investigators will do some control acquisitions.
- In depth micro vessel localization [ Time Frame: During surgery ]Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656407
|Contact: Jean Luc Gennisson, PhD||01 80 96 30 79 ext +email@example.com|
|Contact: Marion IMBAULT||06 58 23 69 52 ext +firstname.lastname@example.org|
|Pitié Salpetriere Hospital||Recruiting|
|Paris, Ile de France, France, 75013|
|Contact: Jean Luc Gennisson, PhD 01 80 96 30 79 ext +33 email@example.com|
|Contact: Marion IMBAULT 0658236952 ext +33 firstname.lastname@example.org|
|Principal Investigator: Dorian Chauvet, MD|
|Principal Investigator:||Dorian Chauvet, MD||Neurosurgery Department|