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NCT04708171Recruiting

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

Erasmus Medical Center

Start Date

1/1/2022

Completion Date

10/1/2026

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.

Eligibility Criteria

Age Range: 18 years to 90 years

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

Interventions

PROCEDURE

Awake mapping under local anesthesia

PROCEDURE

Asleep mapping under general anesthesia

PROCEDURE

Resection under general anesthesia without mapping

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Conditions

Glioblastoma

Locations

University of California, San Francisco

San Francisco, California 94143

United States

Massachusetts General Hospital

Boston, Massachusetts 02114-2696

United States

University Hospitals Leuven

Leuven, Vlaams-Brabant 3000

Belgium

University Hospital Heidelberg

Heidelberg,

Germany

Technical University Munich

Munich,

Germany

Erasmus MC

Rotterdam, South Holland 3015 CE

Netherlands

Medical Center Haaglanden

The Hague, South Holland 2261 CP

Netherlands

Inselspital Universitätsspital Bern

Bern,

Switzerland