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

RecruitingOBSERVATIONAL
Enrollment

453

Participants

Timeline

Start Date

January 1, 2022

Primary Completion Date

October 1, 2025

Study Completion Date

October 1, 2026

Conditions
Glioblastoma
Interventions
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.

Trial Locations (8)

3000

NOT_YET_RECRUITING

University Hospitals Leuven, Leuven

94143

NOT_YET_RECRUITING

University of California, San Francisco, San Francisco

02114-2696

NOT_YET_RECRUITING

Massachusetts General Hospital, Boston

Unknown

NOT_YET_RECRUITING

University Hospital Heidelberg, Heidelberg

NOT_YET_RECRUITING

Technical University Munich, Munich

NOT_YET_RECRUITING

Inselspital Universitätsspital Bern, Bern

3015 CE

RECRUITING

Erasmus MC, Rotterdam

2261 CP

NOT_YET_RECRUITING

Medical Center Haaglanden, The Hague

Sponsors
All Listed Sponsors
collaborator

Medical Center Haaglanden

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

collaborator

University of California, San Francisco

OTHER

lead

Erasmus Medical Center

OTHER