Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708171
Status:
RECRUITING
Last Update Posted:
2022-05-06
First Post:
2020-11-26
Brief Title:
The PROGRAM-study Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The PROGRAM-study Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
Status:
RECRUITING
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROGRAM
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None