Actively Recruiting
The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
Led by Erasmus Medical Center · Updated on 2022-05-06
453
Participants Needed
8
Research Sites
247 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
M
Medical Center Haaglanden
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and 90 years or younger
- Tumor diagnosed as glioblastoma on MRI as assessed by the neurosurgeon
- Tumors located in or near eloquent brain areas such as motor cortex, sensory cortex, pyramidal tract, speech areas, or visual areas as seen on MRI
- Tumor considered suitable for surgical removal by the neurosurgeon
- Written informed consent provided
You will not qualify if you...
- Tumors located in the cerebellum, brain stem, or midline
- Presence of multifocal contrast-enhancing lesions
- Medical conditions preventing MRI, such as having a pacemaker
- Inability to provide written informed consent, for example due to a severe language barrier
- Having a second primary cancer within the past 5 years, except for treated in situ carcinoma or basal cell carcinoma of the skin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Not Yet Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
Not Yet Recruiting
3
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Not Yet Recruiting
4
University Hospital Heidelberg
Heidelberg, Germany
Not Yet Recruiting
5
Technical University Munich
Munich, Germany
Not Yet Recruiting
6
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CE
Actively Recruiting
7
Medical Center Haaglanden
The Hague, South Holland, Netherlands, 2261 CP
Not Yet Recruiting
8
Inselspital Universitätsspital Bern
Bern, Switzerland
Not Yet Recruiting
Research Team
J
Jasper Gerritsen, MD
CONTACT
A
Arnaud Vincent, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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