Intraoperative Functional Ultrasound (FUSIMAGINE)
Primary Purpose
Brain Tumor, Brain Lesion
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound device
Sponsored by
About this trial
This is an interventional health services research trial for Brain Tumor focused on measuring Functional Ultrasound, Intraoperative, Brain, Doppler, Ultrasound
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
Sites / Locations
- Pitié Salpetriere Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasensitive Doppler
Arm Description
Intraoperative ultrasensitive Doppler acquisitions by using an ultrasound device for functional area detection
Outcomes
Primary Outcome Measures
Activation maps through intraoperative ultrasensitive Doppler compared to gold standards cortical simulation mapping and functional MRI
Secondary Outcome Measures
Sensitivity test of the new Doppler mode
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
Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler.
Full Information
NCT ID
NCT02656407
First Posted
December 17, 2015
Last Updated
August 25, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT02656407
Brief Title
Intraoperative Functional Ultrasound
Acronym
FUSIMAGINE
Official Title
Doppler Ultrasonore Ultrasensible Peropératoire du Cerveau - Vers Une Aide Temps Reel à la Cartographie Corticale Fonctionnelle
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
February 11, 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Brain Lesion
Keywords
Functional Ultrasound, Intraoperative, Brain, Doppler, Ultrasound
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasensitive Doppler
Arm Type
Experimental
Arm Description
Intraoperative ultrasensitive Doppler acquisitions by using an ultrasound device for functional area detection
Intervention Type
Device
Intervention Name(s)
Ultrasound device
Intervention Description
Ultrasensitive Doppler acquisition obtained with the Aixplorer ultrasound device
Primary Outcome Measure Information:
Title
Activation maps through intraoperative ultrasensitive Doppler compared to gold standards cortical simulation mapping and functional MRI
Time Frame
During the surgery
Secondary Outcome Measure Information:
Title
Sensitivity test of the new Doppler mode
Description
fUS method will be tested for different types of stimuli and intensity and the investigators will do some control acquisitions.
Time Frame
During surgery
Title
In depth micro vessel localization
Description
Blood vessel density observed with a conventional Doppler will be compared to the one measured with the ultrasensitive Doppler.
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorian Chauvet, MD
Organizational Affiliation
Neurosurgery Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pitié Salpetriere Hospital
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25955583
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.
Results Reference
background
Learn more about this trial
Intraoperative Functional Ultrasound
We'll reach out to this number within 24 hrs