Impact of iMRI on the Extent of Resection in Patients With Newly Diagnosed Glioblastomas
Status:
Completed
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
Summary
Standard treatment of glioblastomas (GBMs) consists of microsurgical resection followed by
concomitant chemoradiation. The extent of resection is one of the most important prognostic
factors with significant influence on the survival of patients. State of the art technique to
achieve the most radical resection possible in conventional surgery is fluorescence-guidance
with 5-aminolevulinic acid (5-ALA). If available, intraoperative MRI (iMRI)-guided tumor
resection enables an intraoperative resection control and subsequent continuation of surgery
if contrast enhancing tumor remnants are found. Therefore a more radical resection and longer
survival of patients might be possible. To date no comparison of these two leading
technologies for GBM-surgery is available to identify the best surgical therapy of this fatal
disease and to justify significant healthcare-economic differences between both technologies.
Goal of this study is to assess the value of iMRI guidance in the resection of GBMs in
comparison to conventional 5-ALA microsurgery. Primary endpoint is the number of total
resections (no residual contrast enhancement) in the postoperative MRI (T1+CM within 48 hours
after surgery) in each group. Secondary endpoints are perioperative clinical data,
progression free survival, patients' clinical condition and overall survival.
The study design was chosen to be a parallel-group approach to compare iMRI and 5-ALA centers
(n=13) to exclude possible bias which might be found by randomizing patients within
individual iMRI centers and to have surgeons with the most experience possible in use of each
respective technology.