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

Part of paid clinical trials in San Francisco, California.

Sponsor
Erasmus Medical Center
Study ID
NCT06273176
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 90 Years
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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).

Key Dates

Start date
Jan 1, 2023
Status verified
Feb 2024
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
225 participants (estimated)

Arms

  • Arm: Awake mapping
    Awake mapping: Tumor resection with intraoperative awake motor or language mapping
  • Arm: Asleep mapping
    Asleep mapping: Tumor resection with intraoperative asleep motor mapping
  • Arm: No mapping
    No mapping: Tumor resection without intraoperative mapping

Primary Outcome Measure

Residual volume [ Time Frame: Within 72 hours postoperatively ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Mitchel Berger, MD PhD
Massachusetts General HospitalBostonMassachusetts02114
Brian Nahed, MD PhD

Find similar trials in San Francisco, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of California, San Francisco· San Francisco, CAMassachusetts General Hospital· Boston, MA

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