Not currently recruiting at UCSF

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

a study on Astrocytoma Glioblastoma Glioma

Summary

Eligibility
for people ages 18-90 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Keywords

Glioblastoma, Anesthetics, Awake mapping under local anesthesia, Asleep mapping under general anesthesia, Resection under general anesthesia without mapping

Eligibility

You can join if…

Open to people ages 18-90

  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

You CAN'T join if...

  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

Locations

  • UCSF not yet accepting patients
    San Francisco California 94143 United States
  • Massachusetts General Hospital not yet accepting patients
    Boston Massachusetts 02114-2696 United States
  • Erasmus MC accepting new patients
    Rotterdam Zuid-Holland 3015 CE Netherlands
  • Medical Center Haaglanden not yet accepting patients
    The Hague Zuid-Holland 2261 CP Netherlands

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Erasmus Medical Center
ID
NCT04708171
Study Type
Observational
Participants
Expecting 453 study participants
Last Updated