RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-01-01
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04708171

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 years and ≤ 90 years
  2. 2. Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon
  3. 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. 4. The tumor is suitable for resection (according to neurosurgeon)
  5. 5. Written informed consent
  1. 1. Tumors of the cerebellum, brain stem or midline
  2. 2. Multifocal contrast enhancing lesions
  3. 3. Medical reasons precluding MRI (e.g. pacemaker)
  4. 4. Inability to give written informed consent (e.g. because of severe language barrier)
  5. 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

Contacts and Locations

Study Contact

Jasper Gerritsen, MD
CONTACT
+31629119553
j.gerritsen@erasmusmc.nl
Arnaud Vincent, MD PhD
CONTACT
a.vincent@erasmusmc.nl

Principal Investigator

Jasper Gerritsen, MD
STUDY_DIRECTOR
Erasmus Medical Center

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
United States

Collaborators and Investigators

Sponsor: Erasmus Medical Center

  • Jasper Gerritsen, MD, STUDY_DIRECTOR, Erasmus Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-01
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2022-01-01
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Glioblastoma