Status:
COMPLETED
Systemic and Local Levels of Lidocaine During Surgery for the Removal of Glioblastoma
Lead Sponsor:
Kiarash Shahlaie, M.D., Ph.D.
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 t...
Eligibility Criteria
Inclusion
- \>= 18 years of age
- Preoperative imaging characteristics consistent with brain glioblastoma (magnetic resonance imaging \[MRI\] brain)
- Patients who are undergoing neurosurgical resection for treatment of glioblastoma
- Ability to understand and willingness to sign an informed consent form
- Ability to adhere to the study visit schedule and other protocol requirements
Exclusion
- Prior treatment for glioblastoma
- Glioblastoma size less than 5 cm\^3
- Known allergy against amide type of local anesthetics
- History of severe cardiac failure (determined by clinical history of less the 3 Metabolic Equivalent of Tasks \[METs\])
- 2nd or 3rd degree heart block (exception: patients with pacemaker)
- Concurrent treatment with class I or III antiarrhythmics (phenytoin, procainamide, propranolol, quinidine) or amiodarone use =\< 3 months
- History of Wolff-Parkinson-White syndrome, Stokes Adams syndrome, or active dysrhythmia
- History of bradycardia
- Prior clinical history of severe hepatic impairment or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 1.55 times of upper normal limit
- Prior clinical history of severe renal impairment or estimated glomerular filtration rate (EGFR) \< 30ml/min
- Uncontrolled seizure disorder
- Acute porphyria
- Patients requiring an awake fiberoptic intubation due to administration of additional lidocaine
- Pregnant or lactating women
- Any condition that would prohibit the understanding or rendering of informed consent
- Any medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that in the opinion of the investigator would prevent the subject from participating and adhering to study related procedures
- Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient's safety or compliance on trial
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04716699
Start Date
January 20 2021
End Date
January 24 2022
Last Update
April 11 2023
Active Locations (1)
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1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817