The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

453 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2026-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study is designed as an international, multicenter prospective cohort study. Patients with presumed glioblastoma (GBM) in- or near eloquent areas on diagnostic MRI will be selected by neurosurgeons. Patients will be treated following one of three study arms: 1) a craniotomy where the resection boundaries for motor or language functions will be identified by the "awake" mapping technique (awake craniotomy, AC); 2) a craniotomy where the resection boundaries for motor functions will be identified by "asleep" mapping techniques (MEPs, SSEPs, continuous dynamic mapping); 3) a craniotomy where the resection boundaries will not be identified by any mapping technique ("no mapping group"). All patients will receive follow-up according to standard practice.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06273176

Glioblastoma, IDH-wildtype Glioblastoma Glioblastoma Multiforme of Brain +6 more

RECRUITING

The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)

NCT06118723

Glioblastoma High-grade Glioma Glioblastoma, IDH-wildtype +9 more

RECRUITING

The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.

NCT03861299

Glioblastoma Glioblastoma Multiforme Glioblastoma Multiforme of Brain +4 more

RECRUITING NA

Automatic Segmentation MRI Cerebral Glioma

NCT04674579

Cerebral Glioblastoma

UNKNOWN

Supramarginal Resection in Glioblastoma Guided by Artificial Intelligence

NCT05735171

Glioblastoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioblastoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Awake mapping under local anesthesia

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Awake mapping under local anesthesia

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.

Intervention Type PROCEDURE

Asleep mapping under general anesthesia

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.

Intervention Type PROCEDURE

Resection under general anesthesia without mapping

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥18 years and ≤ 90 years
2. Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon
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)
4. The tumor is suitable for resection (according to neurosurgeon)
5. Written informed consent

Exclusion Criteria

1. Tumors of the cerebellum, brain stem or midline
2. Multifocal contrast enhancing lesions
3. Medical reasons precluding MRI (e.g. pacemaker)
4. Inability to give written informed consent (e.g. because of severe language barrier)
5. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jasper Gerritsen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jasper Gerritsen, MD

Role: STUDY_DIRECTOR

Erasmus Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.