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

Inclusion Criteria5

Age ≥18 years and ≤ 90 years
Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon
Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)
The tumor is suitable for resection (according to neurosurgeon)
Written informed consent

Exclusion Criteria5

Tumors of the cerebellum, brain stem or midline
Multifocal contrast enhancing lesions
Medical reasons precluding MRI (e.g. pacemaker)
Inability to give written informed consent (e.g. because of severe language barrier)
Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin

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.