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

NCT06273176 | Recruiting

• 1 other identifier: MEC-2020-0812
• Study Type: observational
• Target: 225
• Locations: 5 countries
• Sites: 8

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).

Conditions

Glioblastoma, IDH-wildtype; Glioblastoma; Glioblastoma Multiforme of Brain; Astrocytoma, Malignant; Brain Neoplasms; Brain Neoplasms, Adult, Malignant; Brain Neoplasms, Adult; Recurrent Adult Brain Tumor; Recurrent Glioblastoma

Keywords

Glioblastoma; Recurrent; Re-resection; Resection; Intraoperative mapping; Awake mapping; Awake craniotomy; Asleep mapping; Motor mapping; Language mapping; Overall survival; Progression-free survival; Neurological morbidity; Quality of life; Functional area; Eloquent; Extent of resection; Residual tumor volume

Outcome Measures

Primary Outcomes (2)

• Residual volume

  Residual tumor volume of the contrast-enhancing and non-contrast enhancing part, as assessed by a neuroradiologist on postoperative MRI scan (T1 with contrast and FLAIR sequences) using manual or semi-automatic volumetric analyses (Brainlab Elements iPlan CMF Segmentation, Brainlab AG, Munich, Germany; or similar software)

  Within 72 hours postoperatively

• Neurological morbidity at 6 weeks

  NIHSS deterioration of 1 point or more at 6 weeks after surgery

  6 weeks postoperatively

Secondary Outcomes (18)

• Overall survival

  Up to 5 years postoperatively

• Progression-free survival

  Up to 5 years postoperatively

• Onco-functional outcome (OFO)

  6 weeks postoperatively

• Serious Adverse Events

  6 weeks postoperatively

• Neurological morbidity at 3 months

  3 months postoperatively

Study Arms (3)

Awake mapping

Awake mapping: Tumor resection with intraoperative awake motor or language mapping

Procedure: Awake mapping under local anesthesia

Asleep mapping

Asleep mapping: Tumor resection with intraoperative asleep motor mapping

Procedure: Asleep mapping under general anesthesia

No mapping

No mapping: Tumor resection without intraoperative mapping

Procedure: Resection under general anesthesia without mapping

Interventions

Awake mapping under local anesthesia PROCEDURE

During an awake craniotomy, the patient is awake and cooperative during the resection of the tumor while the surgeon uses electro(sub)cortical mapping to prevent damage to eloquent areas.

Also known as: Awake craniotomy

Awake mapping

Asleep mapping under general anesthesia PROCEDURE

During asleep mapping under general anesthesia, the surgeon uses electro(sub)cortical mapping with evoked potentials (MEPs, SSEPs or continuous dynamic mapping) to prevent damage to eloquent areas.

Also known as: Asleep motor mapping, Continous dynamic mapping, Evoked potentials

Asleep mapping

Resection under general anesthesia without mapping PROCEDURE

During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.

No mapping

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with recurrent glioblastoma will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals, located in Europe and the United States. The study is carried out by centers from the ENCRAM Consortium.

You may qualify if:

• Age ≥18 years and ≤90 years
• Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma
• 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
• The tumor is suitable for resection (according to neurosurgeon)
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Haaglanden Medical Centre: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• University Hospital Heidelberg: collaborator
• Technical University of Munich: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Massachusetts General Hospital: collaborator
• University of California, San Francisco: collaborator

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, 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, 3015 GD, Netherlands

RECRUITING

Haaglanden Medical Center

The Hague, Netherlands

RECRUITING

Inselspital Universitätsspital Bern

Bern, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Glioblastoma; Astrocytoma; Brain Neoplasms; Recurrence

Interventions

Evoked Potentials

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jasper Gerritsen, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasper Gerritsen, MD PhD

CONTACT

+31107036130; j.gerritsen@erasmusmc.nl

Arnaud Vincent, MD PhD

CONTACT

+31107034211; a.vincent@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 22, 2024
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 22, 2024

Record last verified: 2024-02

Locations

BE (1); DE (2); US (2); CH (1); NL (2)