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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥18 years and ≤ 90 years 2. Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon 3. 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) 4. The tumor is suitable for resection (according to neurosurgeon) 5. Written informed consent

Exclusion Criteria

  1. Tumors of the cerebellum, brain stem or midline 2. Multifocal contrast enhancing lesions 3. Medical reasons precluding MRI (e.g. pacemaker) 4. Inability to give written informed consent (e.g. because of severe language barrier) 5. 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Awake mapping under local anesthesia
  • Procedure: Awake 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.
Asleep mapping under general anesthesia
  • Procedure: Asleep 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.
Resection under general anesthesia without mapping
  • Procedure: Resection 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.

More Details

Status
Recruiting
Sponsor
Erasmus Medical Center

Study Contact

Jasper Gerritsen, MD
+31629119553
j.gerritsen@erasmusmc.nl

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.