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

Erasmus University

Status: Enrolling

Conditions: Glioblastoma

Treatments: Procedure: Resection under general anesthesia without mapping; Procedure: Asleep mapping under general anesthesia; Procedure: Awake mapping under local anesthesia

Study type: Observational

Funder types: Other

Identifiers

NCT04708171

MEC-2020-081-2

Details and patient eligibility

About

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.

Enrollment: 453 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

453 participants in 3 patient groups

Awake mapping under local anesthesia

Treatment:

Procedure: Awake mapping under local anesthesia

Asleep mapping under general anesthesia

Treatment:

Procedure: Asleep mapping under general anesthesia

Resection under general anesthesia without mapping

Treatment:

Procedure: Resection under general anesthesia without mapping