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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California, San Francisco
NOT_YET_RECRUITING
San Francisco
Massachusetts
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
Other Locations
Belgium
University Hospitals Leuven
NOT_YET_RECRUITING
Leuven
Germany
University Hospital Heidelberg
NOT_YET_RECRUITING
Heidelberg
Technical University Munich
NOT_YET_RECRUITING
Munich
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Medical Center Haaglanden
NOT_YET_RECRUITING
The Hague
Switzerland
Inselspital Universitätsspital Bern
NOT_YET_RECRUITING
Bern
Contact Information
Primary
Jasper Gerritsen, MD
j.gerritsen@erasmusmc.nl
+31629119553
Backup
Arnaud Vincent, MD PhD
a.vincent@erasmusmc.nl
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 453
Treatments
Awake mapping under local anesthesia
Asleep mapping under general anesthesia
Resection under general anesthesia without mapping
Sponsors
Collaborators: Universitaire Ziekenhuizen KU Leuven, Medical Center Haaglanden, University of California, San Francisco
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov