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NCT06273176 · ClinicalTrials.gov registry record
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
A clinical trial of Glioblastoma and Recurrent Glioblastoma, sponsored by Erasmus Medical Center.
- Recruiting
- Registry status
- 225
- Enrollment target
- 8
- Study locations
NCT06273176 is a study of Glioblastoma and Recurrent Glioblastoma that is actively recruiting participants, run by Erasmus Medical Center. The registered enrollment target is 225 participants, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (108% higher). The trial reports 8 study locations across 4 states.
The verdict
NCT06273176, a study of Glioblastoma and Recurrent Glioblastoma, is actively recruiting participants, sponsored by Erasmus Medical Center.
- RECRUITING
- Registry status
- 225 participants
- Enrollment target
- 8
- Study locations
Study Summary
Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma. This study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).
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 Leuven - Leuven
- Universitätsklinikum Heidelberg - Heidelberg
- Technical University Munich - Munich
- Haaglanden Medical Center - The Hague
- Inselspital Universitätsspital Bern - Bern
California
- University of California, San Francisco - San Francisco
Massachusetts
- Massachusetts General Hospital - Boston
South Holland
- Erasmus Medical Center - Rotterdam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2023-01-01 |
| Est. Completion | 2028-01-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06273176
The ClinicalTrials.gov registry entry for NCT06273176 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (108% higher). The listed sponsor is Erasmus Medical Center, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Awake mapping under local anesthesia is the first listed.
NCT06273176 reports 8 study locations spanning 4 distinct geographic areas - top geographies include Other, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06273176 about?
NCT06273176 is a clinical study titled "The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma". Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evi...
What is the current status of trial NCT06273176?
This trial is currently recruiting. The enrollment target is 225 participants. The study started on 2023-01-01. Estimated completion is 2028-01-01.
What conditions does trial NCT06273176 study?
This clinical trial studies the following conditions: Glioblastoma, Recurrent Glioblastoma, Glioblastoma, IDH-wildtype, Brain Neoplasms, Glioblastoma Multiforme of Brain.
What interventions are being tested in trial NCT06273176?
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 NCT06273176?
This trial is sponsored by Erasmus Medical Center, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06273176 being conducted?
This trial has 8 study locations across California, Massachusetts, South Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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