NCT04708171

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 453 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
PROCEDURE	Awake mapping under local anesthesia	During an awake craniotomy, the patient is awake and cooperative during the resection of the tumor while the surgeon uses electro(sub)cortical mapping to prevent damage to eloquent areas.
PROCEDURE	Asleep mapping under general anesthesia	During asleep mapping under general anesthesia, the surgeon uses electro(sub)cortical mapping with evoked potentials (MEPs, SSEPs or continuous dynamic mapping) to prevent damage to eloquent areas.
PROCEDURE	Resection under general anesthesia without mapping	During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.

Timeline

• Start date: 2022-01-01
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2021-01-13
• Last updated: 2022-05-06

Locations

8 sites across 5 countries: United States, Belgium, Germany, Netherlands, Switzerland