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Application of New Technologies in the Resection of Intracranial Tumors

Application of New Technologies in the Resection of Intracranial Tumors

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03717766
Enrollment
100
Registered
2018-10-24
Start date
2018-10-31
Completion date
2020-09-30
Last updated
2018-10-24

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

Conditions

Intracranial Neoplasm

Brief summary

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.

Interventions

DEVICEintraoperative neuronavigation ultrasound, intraoperative tractography, intraoperative fluorescence, advanced neuronavigation and intraoperative neurophysiology

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

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* intraaxial brain tumors that are tributary to surgical treatment.

Exclusion criteria

* extra-axial brain tumors.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of intracranial tumor resection3 yearsEffectiveness of new intraoperative technologies in the resection of intracranial tumors in terms of percentage of intracranial tumor resection and neurological deficit

Contacts

Primary ContactLaura Salgado, MD
SALGADO1107@HOTMAIL.COM+34687577376

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026