Resection techniques for recurrent glioblastoma
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2301)
This study is testing different methods of mapping the brain during surgery for recurring glioblastoma to see which one helps patients keep their movement and speech abilities while removing as much of the tumor as possible.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | N/A to 90 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT06273176 on ClinicalTrials.gov |
What this trial studies
This study compares the effects of awake mapping, asleep mapping, and no mapping techniques during the resection of recurrent glioblastoma tumors. It is an international, multicenter, prospective cohort study that aims to evaluate the safety and effectiveness of these mapping methods in preserving motor and language functions while maximizing tumor resection. Patients with tumors located in or near eloquent brain areas will be included, and the study will assess the extent of tumor resection and patient outcomes. The study is part of the ENCRAM Research Consortium and involves several prominent neurosurgical centers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with recurrent glioblastoma tumors located in or near eloquent brain areas.
Not a fit: Patients with tumors in the cerebellum, brainstem, or midline, or those with multifocal lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and functional preservation for patients undergoing reoperation for recurrent glioblastoma.
How similar studies have performed: Similar studies have shown success with mapping techniques in newly diagnosed glioblastoma, but the effects in recurrent cases are less understood, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 7 other locations
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University Hospital Leuven — Leuven, Belgium (Recruiting)
- Universitätsklinikum Heidelberg — Heidelberg, Germany (Recruiting)
- Technical University Munich — Munich, Germany (Not_yet_recruiting)
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
- Haaglanden Medical Center — The Hague, Netherlands (Recruiting)
- Inselspital Universitätsspital Bern — Bern, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Jasper Gerritsen, MD PhD — Erasmus Medical Center
- Study coordinator: Jasper Gerritsen, MD PhD
- Email: j.gerritsen@erasmusmc.nl
- Phone: +31107036130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.