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The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
Who can join
Ages 18 to 90 · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Awake mapping under local anesthesia (procedure)
- Asleep mapping under general anesthesia (procedure)
- Resection under general anesthesia without mapping (procedure)
Sponsor: Erasmus Medical Center · Participants: 453 · Started: Jan 1, 2022
Contact the study team
- Jasper Gerritsen, MD · Phone: +31629119553
Official record on ClinicalTrials.gov — NCT04708171
Locations in the U.S.
| California | University of California, San Francisco, San Francisco (Not yet recruiting) |
| Massachusetts | Massachusetts General Hospital, Boston (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.