The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma (NCT06273176)
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2301)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (7 items).
Location: University of California, San Francisco — San Francisco, California
Age range: Not specified to 90 Years
🧪 Interventions in This Study
- Awake mapping under local anesthesia (PROCEDURE)
- Asleep mapping under general anesthesia (PROCEDURE)
- Resection under general anesthesia without mapping (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Tumors of the cerebellum, brainstem, or midline
- Multifocal contrast-enhancing lesions
- Medical reasons precluding MRI (e.g., pacemaker)
- Inability to give written informed consent
- Secondary high-grade glioma due to malignant transformation from low-grade glioma
- Clinical data unavailable for the newly diagnosed setting
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- University of California, San Francisco — San Francisco, California
- Massachusetts General Hospital — Boston, Massachusetts
- University Hospital Leuven — Leuven,
- Universitätsklinikum Heidelberg — Heidelberg,
- Technical University Munich — Munich,
- Erasmus Medical Center — Rotterdam, South Holland
- Haaglanden Medical Center — The Hague,
- Inselspital Universitätsspital Bern — Bern,
📞 Contact the Study Coordinator
Phone: +31107036130
Email: j.gerritsen@erasmusmc.nl
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.