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Application of New Technologies in the Resection of Intracranial Tumors

NCT03717766 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2018-10-24

No results posted yet for this study

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.

Conditions

  • Intracranial Neoplasm

Interventions

DEVICE

intraoperative 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 & Collaborators

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

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2020-09-30
Completion
2020-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03717766 on ClinicalTrials.gov