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

Part of paid clinical trials in San Francisco, California.

Sponsor
Erasmus Medical Center
Study ID
NCT04708171
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 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

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.

Key Dates

Start date
Jan 1, 2022
Status verified
May 2022
Primary completion
Oct 1, 2025
Completion
Oct 1, 2026

Study Design

Enrollment
453 participants (estimated)

Arms

  • Arm: Awake mapping under local anesthesia
  • Arm: Asleep mapping under general anesthesia
  • Arm: Resection under general anesthesia without mapping

Primary Outcome Measure

Neurological morbidity [ Time Frame: Between baseline and 6 weeks/3 months/6 months postoperatively ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Mitchel Berger, Dr.
[email protected]
Massachusetts General HospitalBostonMassachusetts02114-2696
Brian Nahed, Dr.
[email protected]

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By condition
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By specialty
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By research site
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