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Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas


N/A
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas


Inclusion Criteria:



- supratentorial brain tumor, on contrast enhanced dMRI suspected to be GBM

- indication for gross total resection (GTR) of the tumor

- age ≥18 years

- WHO Performance Scale ≤ 2

- ASA class ≤ 3

- adequate knowledge of the Dutch or French language

- informed consent

Exclusion Criteria:

- recurrent brain tumor

- multiple brain tumor localizations

- earlier skull radiotherapy

- earlier chemotherapy for GBM

- Chronic Kidney Disease or other renal function disorder

- known MR-contrast allergy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Difference in Residual tumor volume

Outcome Time Frame:

<72h after surgery

Safety Issue:

No

Principal Investigator

Henk van Santbrink, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maastricht University Medical Center

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

MEC 08-2-055

NCT ID:

NCT00943007

Start Date:

February 2010

Completion Date:

December 2013

Related Keywords:

  • Glioblastoma Multiforme
  • Brain Neoplasms
  • Glioblastoma

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