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Spots Global Cancer Trial Database for Systemic and Local Levels of Lidocaine During Surgery for the Removal of Glioblastoma

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Trial Identification

Brief Title: Systemic and Local Levels of Lidocaine During Surgery for the Removal of Glioblastoma

Official Title: Assessing Systemic and Local Levels of Lidocaine During Surgery for Glioblastoma

Study ID: NCT04716699

Conditions

Glioblastoma

Study Description

Brief Summary: This clinical trial measures the amount and effect of lidocaine injected into patients with glioblastoma while they are undergoing surgical removal of their brain tumors. Lidocaine is a substance used to relieve pain by blocking signals at the nerve endings in skin. Information gained from this study may help researchers come up with new treatments to help patients with glioblastomas in the future.

Detailed Description: PRIMARY OBJECTIVE: I. To assess the pharmacokinetic properties of intravenously administered lidocaine inside a glioblastoma tumor by means of mass spectroscopy. SECONDARY OBJECTIVE: I. To assess the differences in overall survival (OS) and progression free survival (PFS) between the patients in the lidocaine therapy group and historical controls taken from the literature (Stupp et al) with comparable post-operative treatment regimen. OUTLINE: Patients receive bolus lidocaine intravenously (IV) per standard of care. After intubation, patients receive another infusion of lidocaine IV over 4 hours or until the end of surgery. Patients also undergo collection of blood and tumor samples at the start of surgery and hourly afterwards until a total of 4 samples are collected. After completion of surgery, patients are followed for 24 hours, and at 7-14 days, up to 30 days.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Contact Details

Name: Kiarash Shahlaie

Affiliation: University of California, Davis

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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