The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections

Recruiting now

Conditions studied: Glioblastoma

In brief

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 facts

Study ID

NCT04708171

Run by

Erasmus Medical Center

People needed

453

Starts

2022-01-01

Expected to finish

2026-10-01

Last updated by the study team

2022-05-06

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Erasmus MC — Rotterdam, South Holland, Netherlands (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University Hospitals Leuven — Leuven, Vlaams-Brabant, Belgium
• University Hospital Heidelberg — Heidelberg, Germany
• Technical University Munich — Munich, Germany
• Medical Center Haaglanden — The Hague, South Holland, Netherlands
• University of California, San Francisco — San Francisco, California, United States
• Inselspital Universitätsspital Bern — Bern, Switzerland

Full record on ClinicalTrials.gov

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