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The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
Sponsor: Erasmus Medical Center
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.
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
OBSERVATIONAL
Enrollment
453
Start Date
2022-01-01
Completion Date
2026-10-01
Last Updated
2022-05-06
Healthy Volunteers
No
Conditions
Interventions
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
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
During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.
Locations (8)
University of California, San Francisco
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
University Hospital Heidelberg
Heidelberg, Germany
Technical University Munich
Munich, Germany
Erasmus MC
Rotterdam, South Holland, Netherlands
Medical Center Haaglanden
The Hague, South Holland, Netherlands
Inselspital Universitätsspital Bern
Bern, Switzerland