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The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
NCT06273176 · View on ClinicalTrials.gov ↗
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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Erasmus Medical Center, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06273176 reports 8 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Brain Neoplasms, Glioblastoma Multiforme of Brain, Glioblastoma, IDH-wildtype. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06273176?
This trial is sponsored by Erasmus Medical Center, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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