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NCT04708171 · ClinicalTrials.gov registry record
The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections
A clinical trial of Glioblastoma, sponsored by Erasmus Medical Center.
- Recruiting
- Registry status
- 453
- Enrollment target
- 8
- Study locations
NCT04708171: Recruiting study of Glioblastoma, sponsored by Erasmus Medical Center.
NCT04708171 is a study of Glioblastoma that is actively recruiting participants, run by Erasmus Medical Center. The registered enrollment target is 453 participants, above the 107-participant average among 199 other Glioblastoma trials with a reported enrollment target (323% higher). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04708171, a study of Glioblastoma, is actively recruiting participants, sponsored by Erasmus Medical Center.
- RECRUITING
- Registry status
- 453 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
NIHSS deterioration of 1 point or more as compared to baseline value.
Conditions Studied
Interventions
- PROCEDURE Awake mapping under local anesthesia
- PROCEDURE Asleep mapping under general anesthesia
- PROCEDURE Resection under general anesthesia without mapping
Study Locations (8)
Other
- University Hospital Heidelberg - Heidelberg
- Technical University Munich - Munich
- Inselspital Universitätsspital Bern - Bern
South Holland
- Erasmus MC - Rotterdam
- Medical Center Haaglanden - The Hague
California
- University of California, San Francisco - San Francisco
Massachusetts
- Massachusetts General Hospital - Boston
Vlaams-Brabant
- University Hospitals Leuven - Leuven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2026-10-01 |
What NCT04708171 shows while recruiting
NCT04708171 is an observational study that tracks outcomes without assigning an intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, above the 107-participant average among 199 other Glioblastoma trials with a reported enrollment target (323% higher).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Awake mapping under local anesthesia is the first listed.
NCT04708171 lists 8 locations in 5 states (Other, South Holland, California).
Frequently Asked Questions
What is clinical trial NCT04708171 about?
NCT04708171 is a clinical study titled "The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections". 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 b...
What is the current status of trial NCT04708171?
This trial is currently recruiting. The enrollment target is 453 participants. The study started on 2022-01-01. Estimated completion is 2026-10-01.
What conditions does trial NCT04708171 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT04708171?
The interventions under investigation include: Awake mapping under local anesthesia (PROCEDURE), Asleep mapping under general anesthesia (PROCEDURE), Resection under general anesthesia without mapping (PROCEDURE).
Who is sponsoring clinical trial NCT04708171?
This trial is sponsored by Erasmus Medical Center, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04708171 being conducted?
This trial has 8 study locations across California, Massachusetts, Vlaams-Brabant, South Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04708171's enrollment target sits among peer trials
453 13th of 199 higher than 187 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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