RecruitingRecruiting
The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
NCT04708171 · Erasmus Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this 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.
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
Study design
Enrollment target: 453 participants
Age groups: adult, older_adult
Timeline
Starts: 2022-01-01
Estimated completion: 2026-10-01
Last updated: 2022-05-06
Interventions
Procedure: Awake mapping under local anesthesiaProcedure: Asleep mapping under general anesthesiaProcedure: Resection under general anesthesia without mapping
Primary outcomes
- • Neurological morbidity (Between baseline and 6 weeks/3 months/6 months postoperatively)
- • Extent of resection (Assessed within 72 hours on postoperative MRI scan)
Sponsor
Erasmus Medical Center · other
With: Medical Center Haaglanden, Universitaire Ziekenhuizen KU Leuven, University of California, San Francisco
Contacts & investigators
ContactJasper Gerritsen, MD · contact · j.gerritsen@erasmusmc.nl · +31629119553
ContactArnaud Vincent, MD PhD · contact · a.vincent@erasmusmc.nl
InvestigatorJasper Gerritsen, MD · study_director, Erasmus Medical Center
All locations (8)
University of California, San FranciscoNot Yet Recruiting
San Francisco, California, United States
Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, United States
University Hospitals LeuvenNot Yet Recruiting
Leuven, Vlaams-Brabant, Belgium
University Hospital HeidelbergNot Yet Recruiting
Heidelberg, Germany
Technical University MunichNot Yet Recruiting
Munich, Germany
Erasmus MCRecruiting
Rotterdam, South Holland, Netherlands
Medical Center HaaglandenNot Yet Recruiting
The Hague, South Holland, Netherlands
Inselspital Universitätsspital BernNot Yet Recruiting
Bern, Switzerland