The PROGRAM-study: Glioblastoma Resection Techniques

This study is looking at different ways to remove glioblastoma (a type of brain tumor) that is located near important brain areas. Doctors want to see how well three different surgical approaches work: awake mapping (where you are awake during part of the surgery), asleep mapping (where you are asleep, but special tools are used to guide the surgeon), or surgery without mapping. You might be able to join if you are between 18 and 90 years old and have a glioblastoma near areas of the brain that control movement, speech, or vision. The study will measure how well the tumor is removed and if there are any new neurological problems after surgery. The current recruitment status is unclear.

Study design
This is an international study involving many centers, planning to include 453 participants. It is an observational study, meaning researchers will watch and record what happens with each surgical approach.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will have follow-up appointments according to standard practice, with neurological health checked at 6 weeks, 3 months, and 6 months after surgery. Tumor removal will be checked within 72 hours of surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04708171

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

Recruiting
Not specifiedAges 18–90Observational
Erasmus Medical Center
~453 participants
Updated 2022-05-06 on ClinicalTrials.gov
What's tested:Awake mapping under local anesthesiaAsleep mapping under general anesthesiaResection under general anesthesia without mapping

At a glance

Recruiting sites
1 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurological morbidity
Measured over Between baseline and 6 weeks/3 months/6 months postoperatively
+1 more outcome measured
Glioblastoma
8 sites across 6 states
Germany2
South Holland2
California1
Massachusetts1
Vlaams-Brabant1
Switzerland1
  • Jasper Gerritsen, MD · STUDY_DIRECTOR · Erasmus Medical Center

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  • Neurological morbidityBetween baseline and 6 weeks/3 months/6 months postoperatively

    NIHSS deterioration of 1 point or more as compared to baseline value.

  • Extent of resectionAssessed within 72 hours on postoperative MRI scan

    Resection percentage as assessed by an independent neuroradiologist on MRI contrast images with volumetric analysis