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The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma

Recruitingn/aAges any - 90 YearsAllErasmus Medical Center
NCT06273176 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 w

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥18 years and ≤90 years 2. Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma 3. Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)19 4. The tumor is suitable for resection (according to neurosurgeon) 5. Written informed consent Exclusion Criteria: 1. Tumors of the cerebellum, brainstem, or midline 2. Multifocal contrast-enhancing lesions 3. Medical reasons precluding MRI (e.g., pacemaker) 4. Inability to give written informed consent 5. Secondary high-grade glioma due to malignant transformation from low-grade glioma 6. Clinical data unavailable for the newly diagnosed setting
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What it tests

  • Awake mapping under local anesthesia
  • Asleep mapping under general anesthesia
  • Resection under general anesthesia without mapping
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Where

8 sites
University of California, San Francisco
San Francisco, United States
Massachusetts General Hospital
Boston, United States
University Hospital Leuven
Leuven, Belgium
Universitätsklinikum Heidelberg
Heidelberg, Germany
Technical University Munich
Munich, Germany
Erasmus Medical Center
Rotterdam, Netherlands
Haaglanden Medical Center
The Hague, Netherlands
Inselspital Universitätsspital Bern
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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