Status:
RECRUITING
The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Medical Center Haaglanden
Universitaire Ziekenhuizen KU Leuven
Conditions:
Glioblastoma
Eligibility:
All Genders
18-90 years
Brief 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 neurosurgeon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT04708171
Start Date
January 1 2022
End Date
October 1 2026
Last Update
May 6 2022
Active Locations (8)
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1
University of California, San Francisco
San Francisco, California, United States, 94143
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
3
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
4
University Hospital Heidelberg
Heidelberg, Germany