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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55740
Enrollment
75
Registered
2018-07-31
Start date
2018-10-10
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AVM braintumor glioma vascular abnormality

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To assess the potential ability of fUS to discriminate between functional and non-functional brain areas using task-specific brain-activity during an awake neurosurgical procedure.

Secondary

MeasureTime frame
To assess the potential use of fUS as a means to discriminate between healthy and pathological tissue (tumor and AVMs) using CBV and/or CEUS CBV measurements to visualize vascularization differences in these tissues during both awake (tumor) and non-awake (tumor and AVM) neurosurgical procedures.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)