RecruitingNCT04708171

The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections

Sponsor

Erasmus Medical Center

Enrollment

453 participants

Start Date

Jan 1, 2022

Study Type

OBSERVATIONAL

Conditions

Glioblastoma

Summary

The study is designed as an international, multicenter prospective cohort study. Patients with presumed glioblastoma (GBM) in- or near eloquent areas on diagnostic MRI will be selected by neurosurgeons. Patients will be treated following one of three study arms: 1) a craniotomy where the resection boundaries for motor or language functions will be identified by the "awake" mapping technique (awake craniotomy, AC); 2) a craniotomy where the resection boundaries for motor functions will be identified by "asleep" mapping techniques (MEPs, SSEPs, continuous dynamic mapping); 3) a craniotomy where the resection boundaries will not be identified by any mapping technique ("no mapping group"). All patients will receive follow-up according to standard practice.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study (the PROGRAM study) is comparing three surgical approaches for removing glioblastoma brain tumors — awake brain surgery with brain mapping, brain mapping under general anesthesia, and standard surgery without any brain mapping — to see which approach best preserves brain function and maximizes tumor removal. **You may be eligible if...** - You are 18 to 90 years old - Your MRI shows a glioblastoma tumor near important brain areas (motor, sensory, speech, or vision regions) - A neurosurgeon has determined the tumor can be surgically removed - You are able to give written informed consent **You may NOT be eligible if...** - Your tumor is in the cerebellum, brain stem, or midline - You have multiple enhancing tumors on imaging - You have a pacemaker or other reason you cannot have an MRI - You are not able to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAwake mapping under local anesthesia

During an awake craniotomy, the patient is awake and cooperative during the resection of the tumor while the surgeon uses electro(sub)cortical mapping to prevent damage to eloquent areas.

PROCEDUREAsleep mapping under general anesthesia

During asleep mapping under general anesthesia, the surgeon uses electro(sub)cortical mapping with evoked potentials (MEPs, SSEPs or continuous dynamic mapping) to prevent damage to eloquent areas.

PROCEDUREResection under general anesthesia without mapping

During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.