Application of New Technologies in the Resection of Intracranial Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years - 85 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- intraaxial brain tumors that are tributary to surgical treatment.

Exclusion Criteria:

- extra-axial brain tumors.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03717766
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Intracranial Neoplasm

Arms & Interventions

Arms

: Patients

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.

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