Application of New Technologies in the Resection of Intracranial Tumors

Study Overview
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Brief Summary
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Main Outcome: To assess the effectiveness of new intraoperative technologies in the resection of intracranial tumors. Design: Prospective observational study. Method: Prospective observational study of the use and effectiveness of intraoperative neuronavigation ultrasound, intraoperative tractography, intraoperative fluorescence, advanced neuronavigation and intraoperative neurophysiology in the resection of intracranial supratentorial tumors. Number of patients: 70 - 100. Duration of the study: 3 years. Ethical considerations: The study will be carried out following the international ethical recommendations for medical research in humans. Before beginning the study, the Ethical Committee of the Hospital of Santa Creu i Sant Pau approved the study protocol. It is about the study of surgical techniques that we use in our usual clinical practice. Fundings: There are no funding sources.

Official Title
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Application of New Technologies in the Resection of Intracranial Tumors

Conditions
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Intracranial Neoplasm

Intervention / Treatment
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* Device: intraoperative neuronavigation ultrasound, intraoperative tractography, intraoperative fluorescence, advanced neuronavigation and intraoperative neurophysiology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: intraaxial brain tumors that are tributary to surgical treatment. Exclusion Criteria: extra-axial brain tumors.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Intraaxial brain tumors that are tributary to surgical treatment. Prospective observational study of the use and effectiveness of intraoperative neuronavigation ultrasound, intraoperative tractography, intraoperative fluorescence, advanced neuronavigation and intraoperative neurophysiology in the resection of intracranial supratentorial tumors. | Device: intraoperative neuronavigation ultrasound, intraoperative tractography, intraoperative fluorescence, advanced neuronavigation and intraoperative neurophysiology<br>* 5-aminolevulinic acid (5-ALA) is a pro-drug that causes fluorescent protoporphyrins that accumulate in malignant gliomas. Fluorescence can be visualized during surgery by the use of a modified microscope, which helps the surgeon define the margins of the tumor. Neuro-navigated intraoperative ultrasound is an imaging technique that allows us to visualize intracranial lesions during surgery and correlate them with the image provided by the neuronavigator, obtaining a real-time view of the lesion and possible tumor remains. To achieve greater tumor resections without increasing the incidence of neurological deficits, the use of intraoperative neuromonitoring has been progressively implemented. This technology and specifically the brain mapping allows us to locate the functional areas of the brain and perform more aggressive resections with lower morbidity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of intracranial tumor resection | Effectiveness of new intraoperative technologies in the resection of intracranial tumors in terms of percentage of intracranial tumor resection and neurological deficit | 3 years |