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

NCT04708171 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Erasmus Medical Center

Phase

Observational

Started

2022-01-01

Last updated

2022-05-06

Condition(s) studied

Glioblastoma

Investigational drug(s) / intervention(s)

Awake mapping under local anesthesiaAsleep mapping under general anesthesiaResection under general anesthesia without mapping

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.

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.

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

90 Years

Healthy volunteers

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

Primary outcome measure(s)

Neurological morbidity — Between baseline and 6 weeks/3 months/6 months postoperatively
NIHSS deterioration of 1 point or more as compared to baseline value.
Extent of resection — Assessed within 72 hours on postoperative MRI scan
Resection percentage as assessed by an independent neuroradiologist on MRI contrast images with volumetric analysis

Trial sites (8)

Facility	City	Region	Status
University of California, San Francisco	San Francisco	California	Not Yet Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Not Yet Recruiting
University Hospitals Leuven	Leuven	Vlaams-Brabant	Not Yet Recruiting
University Hospital Heidelberg	Heidelberg	Germany	Not Yet Recruiting
Technical University Munich	Munich	Germany	Not Yet Recruiting
Erasmus MC	Rotterdam	South Holland	Recruiting
Medical Center Haaglanden	The Hague	South Holland	Not Yet Recruiting
Inselspital Universitätsspital Bern	Bern	Switzerland	Not Yet Recruiting

More Erasmus Medical Center trials in the Netherlands

The Effect of NOn-invasive Respiratory Support on outcoMe and Its Risks in SARS-COV-2-related Hypoxemic Respiratory Failure Recruiting

Piezosurgery Versus Conventional Techniques in Orthognathic Surgery Starting soon

Combining Latency Reversing Agents to Address the HIV Reservoir Starting soon

Follow-up After Surgery for Colorectal Cancer Active, not recruiting

CAMK2-related Synapthopathies Natural History Study Recruiting

Other trials for the same condition

The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302) Recruiting

Biopsy Versus Resection in Elderly Glioblastoma Patients. A Prospective Cohort Study. Starting soon

Physiological MRI for Precision Radiotherapy IDH-wildtype Glioblastoma Active, not recruiting

Hitting the Mark: Introducing State-of-the-art MRI for Precision Radiotherapy of Glioblastoma Recruiting

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04708171 on ClinicalTrials.gov ↗ ← All trials in the Netherlands