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70. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC)
Joint Meeting mit der Skandinavischen Gesellschaft für Neurochirurgie

Deutsche Gesellschaft für Neurochirurgie (DGNC) e. V.

12.05. - 15.05.2019, Würzburg

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Assuring quality and safety in neurosurgery by prospective multicentre trials – introducing the iMRI/5-ALA trial and the LoG-Glio registry

Qualitätssicherung in der Neurochirurgie durch prospektive multizentrische Studien am Beispiel der iMRI/5-ALA Studie und des LoG-Glio Registers

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  • presenting/speaker Constantin Roder - Universitätsklinikum Tübingen, Neurochirurgie, Tübingen, Deutschland
  • Marcel Alexander Kamp - Universität Düsseldorf, Neurochirurgie, Düsseldorf, Deutschland
  • Christian von der Brelie - Universität Göttingen, Neurochirurgie, Göttingen, Deutschland
  • Jan Coburger - Universität Ulm, Neurochirurgie, Günzburg, Deutschland
  • Moritz Scherer - Universität Heidelberg, Neurochirurgie, Heidelberg, Deutschland
  • Christina Hamisch - Universität Köln, Neurochirurgie, Köln, Deutschland
  • Mario Löhr - Universität Würzburg, Neurochirurgie, Würzburg, Deutschland
  • Stephanie Schipmann - Universität Münster, Neurochirurgie, Münster, Deutschland
  • Torben Scholz - Asklepios Klinik Nord, Neurochirurgie, Hamburg, Deutschland
  • Julian Rathert - Helios Klinik Erfurt, Neurochirurgie, Erfurt, Deutschland
  • Rüdiger Gerlach - Helios Klinik Erfurt, Neurochirurgie, Erfurt, Deutschland
  • Florian Stockhammer - Klinikum Dresden Friedrichstadt, Neurochirurgie, Dresden, Deutschland
  • Oliver Ganslandt - Klinikum Stuttgart, Neurochirurgie, Stuttgart, Deutschland
  • Arya Nabavi - International Neuroscience Institut, Neurochirurgie, Hannover, Deutschland
  • Paul Kremer - Asklepios Klinik Nord, Neurochirurgie, Hamburg, Deutschland
  • Walter Stummer - Universität Münster, Neurochirurgie, Münster, Deutschland
  • Ralf-Ingo Ernestus - Universität Würzburg, Neurochirurgie, Würzburg, Deutschland
  • Boris Krischek - Universität Köln, Neurochirurgie, Köln, Deutschland
  • Andreas Unterberg - Universität Heidelberg, Neurochirurgie, Heidelberg, Deutschland
  • Christian Rainer Wirtz - Universität Ulm, Neurochirurgie, Günzburg, Deutschland
  • Veit Rohde - Universität Göttingen, Neurochirurgie, Göttingen, Deutschland
  • Michael Sabel - Universität Düsseldorf, Neurochirurgie, Düsseldorf, Deutschland
  • Marcos Tatagiba - Universitätsklinikum Tübingen, Neurochirurgie, Tübingen, Deutschland

Deutsche Gesellschaft für Neurochirurgie. 70. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), Joint Meeting mit der Skandinavischen Gesellschaft für Neurochirurgie. Würzburg, 12.-15.05.2019. Düsseldorf: German Medical Science GMS Publishing House; 2019. DocV049

doi: 10.3205/19dgnc061, urn:nbn:de:0183-19dgnc0612

Published: May 8, 2019

© 2019 Roder et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

Text

Objective: A maximum safe resection is the crucial first step in the treatment of patients with Glioblastoma. Intraoperative MR and 5-ALA-fluorescence guidance have been shown to provide a good basis to achieve this goal. To date, no high-quality evidence is available to prove if either of both technologies might be more beneficial for patients. Therefore this prospective multicenter trial was initiated by a working group.

Methods: A prospective multicenter parallel group trial with 11 participating centers (centers with iMRI units using iMRI-guided resections with white-light and centers without iMRI using 5-ALA (Gliolan®)-guidance) was initiated. A total of 276 patients (138 in each arm) are planned to be recruited for the participation in this study. Main inclusion criteria are suspected primary untreated glioblastomas with a planned total resection according to the surgeon’s estimation of the preoperative MRI. The primary endpoint is the achievement (yes/no) of a total resection of the tumor in the postoperative MRI (T1+/-CE) within 72h after surgery. Secondary endpoints are perioperative clinical data (surgeon questionnaire, OR time, histology and molecular markers, tumor localization, etc.), morbidity, quality of life and progression free-, as well as overall survival. To ensure inclusion of patients with comparable tumors, a central blinded grading of the tumors will be performed before the final analysis. Postoperative MRI, as well as follow-up imaging will be evaluated by neuroradiologists in a blinded fashion.

Results: Since initiation of the study in 2015 more than 1000 patients were screened. Inclusion criteria were met in approx. 10–20% of all cases with some variability between the centers. By now more than 200 patients were included in the study. Analysis of preoperative data reveal a well balanced and comparable inclusion of patients between both cohorts. Results of the final evaluation after completion of this trial will very likely provide representative data for the use of iMRI and 5-ALA in the resection of Glioblastomas.

Conclusion: While continuously recruiting, the study shows good progress and recruitment will be finished soon. Preliminary analysis of inclusion data show that the study design with parallel recruitment in specialized centers is feasible and representative. Results of this study will be published one year after inclusion of the last patient and might provide new data on advantages and disadvantages of both technologies for the resection of glioblastomas.