- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03179176
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 (EUHF_PRC)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fabien ALMAIRAC, MD
- Phone Number: +33 492038557
- Email: almairac.f@chu-nice.fr
Study Locations
-
-
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Nice, France, 06003
- CHU de Nice
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- operated patient of a cerebral tumor in an awake condition
- age> 18 years
- neurological condition allowing the realization of the tests in the operating room
Exclusion Criteria:
- not indicated for "awake" surgery
- refusal of participation of the patient
- pregnant or nursing women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HFUD utilisation
|
Utilisation of HFUD will be done during on patients during an operation in waking condition.
This procedure extends the usual procedure from 15 to 20 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diameter of the sulcus blood vessels
Time Frame: before resection of the tumor
|
before resection of the tumor
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Collaborators and Investigators
Investigators
- Study Director: Fabien ALMAIRAC, MD, Centre Hospitalier Universitaire de Nice
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17-PP-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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