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Lidocaine levels measured in brain tumors during surgery

NCT ID NCT04716699

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Jan 2021

Finished

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.