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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iMRI-guided surgery | Experimental | Resection of Glioblastomas with iMRI-guidance |
|
| 5-ALA-guided surgery | Active Comparator | Resection of Glioblastomas with 5-ALA-fluorescence-guidance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iMRI-guided surgery | Device | For iMRI-guided glioma resections the surgery can be paused and a direct intraoperative resection control is possible by performing an intraoperative MRI scan. If residual tumor is found, the resection might be continued. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete resections in the postoperative MRI (T1+/-CM) within 48 hours after surgery | Completeness of resection in the postoperative MRI within 48h after surgery. Blinded analysis by an independent radiologist. | 48 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' clinical condition (KPS) | -KPS clinical scoring | preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery |
| Patients' clinical condition (NIHSS) | -NIHSS stroke score |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative tumor localization and resectability concerning eloquent regions | Independent blinded analysis of the preoperative imaging data by a blinded neurosurgeon with extensive experience in the resection of gliomas. Analysis will be done before the final evaluation of results. (Within 12 months) | Blinded analysis of preoperative imaging (not older than 3 days prior to surgery) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Constantin Roder, Dr. | University Hospital Tuebingen, Department of Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, Universitätsklinikum Bonn, Bonn, Germany | Bonn | Germany | ||||
| Department of Neurosurgery, Universität zu Köln, Köln, Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37335962 | Derived | Roder C, Stummer W, Coburger J, Scherer M, Haas P, von der Brelie C, Kamp MA, Lohr M, Hamisch CA, Skardelly M, Scholz T, Schipmann S, Rathert J, Brand CM, Pala A, Ernemann U, Stockhammer F, Gerlach R, Kremer P, Goldbrunner R, Ernestus RI, Sabel M, Rohde V, Tabatabai G, Martus P, Bisdas S, Ganslandt O, Unterberg A, Wirtz CR, Tatagiba M. Intraoperative MRI-Guided Resection Is Not Superior to 5-Aminolevulinic Acid Guidance in Newly Diagnosed Glioblastoma: A Prospective Controlled Multicenter Clinical Trial. J Clin Oncol. 2023 Dec 20;41(36):5512-5523. doi: 10.1200/JCO.22.01862. Epub 2023 Jun 19. |
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| 5-ALA-guided surgery | Drug | For 5-ALA guided glioma resections patients have to drink 100ml of a solution with 5-Aminolevulinic acid 4-6 hours before surgery. Intraoperatively the light source of the surgical microscope can be switched to a certain wave length to enable fluorescence of the glioma cells, which helps resecting the tumor as radical as possible. |
|
| preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery |
| Patients' clinical condition (QoL) | -quality of life (EORTC) questionnaire | preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery |
| ICU and hospital stay after surgery | -ICU and overall hospital stay after surgery | Time of hospital stay (average 7days) |
| Patients' adjuvant treatment | -adjuvant treatment each patient has received | 3Months, 6Months, 9Months, 12Months after surgery |
| Recurrent tumor growth (RANO criteria) | -recurrent tumor growth (RANO criteria) according to local tumor boards and independent blinded analysis | 3Months, 6Months, 9Months, 12Months after surgery |
| Follow-up imaging | -follow-up imaging 3, 6, 9, 12 months postoperative incl. independent blinded analysis | 3Months, 6Months, 9Months, 12Months after surgery |
| Histology | Histological analysis | 1 week after surgery |
| MGMT (O6-methylguanine-DNA-methyltransferase) analysis | MGMT promoter analysis (Routine molecular diagnostics) | 1 week after surgery |
| IDH-1 (isocitrate dehydrogenase) analysis | IDH-1 mutation analysis (Routine molecular diagnostics) | 1 week after surgery |
| Progression-free survival (PFS) | 6M&12M-PFS | Day of surgery - 6 months - 12 months |
| Overall survival (OS) | OS of patients | Day of surgery - Death of patient (Max. 10 years follow-up) |
| Cologne |
| Germany |
| Städtisches Klinikum Dresden Friedrichstadt | Dresden | Germany |
| Department of Neurosurgery, Heinrich-Heine-Universität Düsseldorf, Düsseldorf | Düsseldorf | Germany |
| Department of Neurosurgery, Friedrich-Alexander-University Erlangen-Nürnberg | Erlangen | Germany |
| Department of Neurosurgery, Johann Wolfgang Goethe-University Frankfurt am Main | Frankfurt a.M. | Germany |
| Department of Neurosurgery, Georg-August-Universität Göttingen, Göttingen, | Göttingen | Germany |
| Department of Neurosurgery, University of Ulm, Hospital Günzburg, | Günzburg | Germany |
| Asklepios Klinik Hamburg, Klinik für Neurochirurgie | Hamburg | Germany |
| International Neuroscience Institute Hannover, Hannover, Germany | Hanover | Germany |
| Department of Neurosurgery, Ruprecht-Karls-University Heidelberg | Heidelberg | Germany |
| Department of Neurosurgery, University of Schleswig-Holstein, Kiel, Germany | Kiel | Germany |
| Department of Neurosurgery, Westfälische Wilhelms-Universität Münster, Münster, Germany | Münster | Germany |
| Department of Neurosurgery, Eberhard Karls University, Tübingen, | Tübingen | Germany |
| Department of Neurosurgery, Julius-Maximilians-Universität Würzburg | Würzburg | Germany |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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