Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.


Condition or disease Intervention/treatment Phase
Brain Tumor Brain Lesion Device: Ultrasound device Not Applicable

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Activation maps through intraoperative ultrasensitive Doppler compared to gold standards cortical simulation mapping and functional MRI [ Time Frame: During the surgery ]

Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Jean Luc Gennisson, PhD 01 80 96 30 79 ext +33 jl.gennisson@espci.fr
Contact: Marion IMBAULT 06 58 23 69 52 ext +33 marion.imbault@gmail.com

Locations
Layout table for location information
France
Pitié Salpetriere Hospital Recruiting
Paris, Ile de France, France, 75013
Contact: Jean Luc Gennisson, PhD    01 80 96 30 79 ext +33    jl.gennisson@espci.fr   
Contact: Marion IMBAULT    0658236952 ext +33    marion.imbault@gmail.com   
Principal Investigator: Dorian Chauvet, MD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Layout table for investigator information
Principal Investigator: Dorian Chauvet, MD Neurosurgery Department

Publications:
Layout table for additonal information
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02656407     History of Changes
Other Study ID Numbers: C14-66
2015-A00661-48 ( Registry Identifier: ID-RCB )
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Functional Ultrasound
Intraoperative
Brain
Doppler
Ultrasound