MedPath

Intraoperative functional Ultrasound (fUS)-imaging during awake and anesthetized neurosurgical procedures

Recruiting
Conditions
AVM
braintumor
glioma
vascular abnormality
10029211
10009720
Registration Number
NL-OMON55740
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
75
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet the
following criteria:
- Age > 18 years
- Mentally competent, AND
EITHER
• Undergoing awake craniotomy surgery for the indication of tumor removal with
ESM already planned in the removal of their tumors
OR
• Undergoing non-awake craniotomy surgery for the indication of tumor removal
OR
• Undergoing non-awake craniotomy surgery for the indication of AVM-removal

Exclusion Criteria

- Depression or an anxiety disorder
- Any contra-indication for contrast media Sonovue (Bracco International bv,
Amsterdam): known allergy to Polyethylene Glycol or PEG (macrogol) in
particular, or to PEG-containing products such as certain bowel preps for
colonoscopy or laxatives.
- Pregnant and/or lactating women.
- Not able to provide written Informed Consent

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>To assess the potential ability of fUS to discriminate between functional and<br /><br>non-functional brain areas using task-specific brain-activity during an awake<br /><br>neurosurgical procedure. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>To assess the potential use of fUS as a means to discriminate between healthy<br /><br>and pathological tissue (tumor and AVMs) using CBV and/or CEUS CBV measurements<br /><br>to visualize vascularization differences in these tissues during both awake<br /><br>(tumor) and non-awake (tumor and AVM) neurosurgical procedures. </p><br>
© Copyright 2025. All Rights Reserved by MedPath