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

Randomized Assessment of Conventional Neuronavigation versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas - RACING-project

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35324
Enrollment
27
Registered
2009-03-23
Start date
2010-03-16
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glioblastoma multiforme (GBM) malignant brain tumor

Interventions

Randomization in the iMRI or cNN group, after which treatment will be given as desribed in the summary paragraph "Study Design". Before and after surgery the patient will be requested to fill in som

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
For each treatment group the percentage of residual tumor as visible on the postoperative scan will be compared to tumor volume on the preoperative scan. The main question from the RACING-project is whether iMRI helps to achieve a lower percentage of residual tumor volume compared to cNN.

Secondary

MeasureTime frame
* complications * clinical performance (WHO Performance Scale) / quality of life * survival

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)