NCT06273176 The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
| NCT ID | NCT06273176 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Glioblastoma, IDH-wildtype |
| Study Type | OBSERVATIONAL |
| Enrollment | 225 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 225 participants in total. It began in 2023-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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
Contact & Investigator
Jasper Gerritsen, MD PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06273176 clinical trial?
This trial is open to participants of all sexes, up to 90 Years, studying Glioblastoma, IDH-wildtype. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06273176 currently recruiting?
Yes, NCT06273176 is actively recruiting participants. Contact the research team at j.gerritsen@erasmusmc.nl for enrollment information.
Where is the NCT06273176 trial being conducted?
This trial is being conducted at San Francisco, United States, Boston, United States, Leuven, Belgium, Heidelberg, Germany and 4 additional locations.
Who is sponsoring the NCT06273176 clinical trial?
NCT06273176 is sponsored by Erasmus Medical Center. The principal investigator is Jasper Gerritsen, MD PhD at Erasmus Medical Center. The trial plans to enroll 225 participants.
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