Comparing awake and asleep mapping techniques for glioblastoma surgery

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

This study is testing whether having brain mapping done while awake or asleep helps people with glioblastoma have better surgery outcomes and recoveries compared to not using mapping at all.

Quick facts

• Study type: Observational
• Enrollment: 453 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Erasmus Medical Center (other)
• Locations: 8 sites (San Francisco, California and 7 other locations)
• Trial ID: NCT04708171 on ClinicalTrials.gov

What this trial studies

This international, multicenter observational study aims to evaluate the effectiveness of different mapping techniques during glioblastoma resections. Patients with glioblastoma located in or near critical brain areas will be assigned to one of three groups: awake mapping, asleep mapping, or no mapping at all. The study will assess the outcomes of these approaches in terms of surgical success and patient recovery. Follow-up care will be provided according to standard practices to monitor patient progress.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with glioblastoma tumors located in or near eloquent brain areas suitable for surgical resection.

Not a fit: Patients with tumors in the cerebellum, brain stem, or midline, or those with multifocal lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve surgical outcomes and recovery for patients undergoing glioblastoma resection.

How similar studies have performed: Previous studies have shown promising results with awake mapping techniques, suggesting potential benefits in similar approaches.

Eligibility criteria

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

Where this trial is running

San Francisco, California and 7 other locations

• University of California, San Francisco — San Francisco, California, United States (NOT_YET_RECRUITING)
• Massachusetts General Hospital — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
• University Hospitals Leuven — Leuven, Vlaams-Brabant, Belgium (NOT_YET_RECRUITING)
• University Hospital Heidelberg — Heidelberg, Germany (NOT_YET_RECRUITING)
• Technical University Munich — Munich, Germany (NOT_YET_RECRUITING)
• Erasmus MC — Rotterdam, South Holland, Netherlands (RECRUITING)
• Medical Center Haaglanden — The Hague, South Holland, Netherlands (NOT_YET_RECRUITING)
• Inselspital Universitätsspital Bern — Bern, Switzerland (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Jasper Gerritsen, MD

Conditions: Glioblastoma