Lidocaine levels measured in brain tumors during surgery
NCT ID NCT04716699
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed phase 1 trial measured how much lidocaine, a common pain reliever, reaches the tumor and blood in 12 adults undergoing surgery for glioblastoma. Researchers collected blood and tumor samples at multiple times to understand the drug's levels. The goal was to gather information that might help develop future treatments for this aggressive brain cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lidocaine
- What this could lead to
- If successful, this study could help researchers design new treatments that use lidocaine to improve outcomes for glioblastoma patients.
- What could go wrong
- This is a very small, early-phase study with only 12 participants, focused on measuring drug levels rather than proving any treatment benefit. It may not lead to any new therapies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
12 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Jan 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * \>= 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
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Other studies related to the condition(s) this trial covers.
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