Application of New Technologies in the Resection of Intracranial Tumors

Intracranial Neoplasm Clinical Trial

Official title:

Application of New Technologies in the Resection of Intracranial Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03717766
• Other study ID #: IIBSP-TIC-2018-53
• Status: Not yet recruiting
• Start date: October 2018
• Est. completion date: September 2020

Study information

• Verified date: October 2018
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Laura Salgado, MD
• Phone: +34687577376
• Email: SALGADO1107[@]HOTMAIL.COM
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• intraaxial brain tumors that are tributary to surgical treatment.

Exclusion Criteria:

• extra-axial brain tumors.

Related Conditions & MeSH terms

• Brain Neoplasms
• Intracranial Neoplasm

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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