- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02379572
Impact of iMRI on the Extent of Resection in Patients With Newly Diagnosed Glioblastomas
Impact of iMRI on the Extent of Resection in Patients With Newly Diagnosed Glioblastomas - A Prospective Multicenter Parallel Group Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bonn, Germany
- Department of Neurosurgery, Universitätsklinikum Bonn, Bonn, Germany
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Cologne, Germany
- Department of Neurosurgery, Universität zu Köln, Köln, Germany
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Dresden, Germany
- Städtisches Klinikum Dresden Friedrichstadt
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Düsseldorf, Germany
- Department of Neurosurgery, Heinrich-Heine-Universität Düsseldorf, Düsseldorf
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Erlangen, Germany
- Department of Neurosurgery, Friedrich-Alexander-University Erlangen-Nürnberg
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Frankfurt a.M., Germany
- Department of Neurosurgery, Johann Wolfgang Goethe-University Frankfurt am Main
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Göttingen, Germany
- Department of Neurosurgery, Georg-August-Universität Göttingen, Göttingen,
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Günzburg, Germany
- Department of Neurosurgery, University of Ulm, Hospital Günzburg,
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Hamburg, Germany
- Asklepios Klinik Hamburg, Klinik für Neurochirurgie
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Hannover, Germany
- International Neuroscience Institute Hannover, Hannover, Germany
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Heidelberg, Germany
- Department of Neurosurgery, Ruprecht-Karls-University Heidelberg
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Kiel, Germany
- Department of Neurosurgery, University of Schleswig-Holstein, Kiel, Germany
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Münster, Germany
- Department of Neurosurgery, Westfälische Wilhelms-Universität Münster, Münster, Germany
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Tübingen, Germany
- Department of Neurosurgery, Eberhard Karls University, Tübingen,
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Würzburg, Germany
- Department of Neurosurgery, Julius-Maximilians-Universität Würzburg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- In MRI suspected primary singular untreated GBM
- Planned total resection of the tumor according to the surgeon
- Patient ≥18 years, ≤80 years
- Preoperative KPS ≥ 60%, American Society of Anesthesiologists (ASA) score 1 and 2
- Patients' informed consent
Exclusion Criteria:
- Tumors of the midline, basal ganglia, cerebellum, brain stem, eloquent areas
- Multifocal glioblastoma
- Substantial (>50%), non-contrast enhancing tumor areas suggesting low-grade glioma with malignant transformation
- Contraindications to MRI
- Inability to give consent because of language barrier or dysphasia
- Histological diagnosis other than Glioblastoma multiforme WHO °IV
- Increased risk of thrombosis (e.g. Factor V Leiden)
- Pregnancy or breast feeding
- Hypersensibility for 5-ALA oder porphyrins
- Acute or chronic Porphyria
- Renal insufficiency
- Hepatic insufficiency
- High likelihood of inability to receive adjuvant therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iMRI-guided surgery
Resection of Glioblastomas with iMRI-guidance
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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.
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Active Comparator: 5-ALA-guided surgery
Resection of Glioblastomas with 5-ALA-fluorescence-guidance
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete resections in the postoperative MRI (T1+/-CM) within 48 hours after surgery
Time Frame: 48 hour
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Completeness of resection in the postoperative MRI within 48h after surgery.
Blinded analysis by an independent radiologist.
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48 hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients' clinical condition (KPS)
Time Frame: preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery
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-KPS clinical scoring
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preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery
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Patients' clinical condition (NIHSS)
Time Frame: preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery
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-NIHSS stroke score
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preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery
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Patients' clinical condition (QoL)
Time Frame: preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery
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-quality of life (EORTC) questionnaire
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preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery
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ICU and hospital stay after surgery
Time Frame: Time of hospital stay (average 7days)
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-ICU and overall hospital stay after surgery
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Time of hospital stay (average 7days)
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Patients' adjuvant treatment
Time Frame: 3Months, 6Months, 9Months, 12Months after surgery
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-adjuvant treatment each patient has received
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3Months, 6Months, 9Months, 12Months after surgery
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Recurrent tumor growth (RANO criteria)
Time Frame: 3Months, 6Months, 9Months, 12Months after surgery
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-recurrent tumor growth (RANO criteria) according to local tumor boards and independent blinded analysis
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3Months, 6Months, 9Months, 12Months after surgery
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Follow-up imaging
Time Frame: 3Months, 6Months, 9Months, 12Months after surgery
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-follow-up imaging 3, 6, 9, 12 months postoperative incl.
independent blinded analysis
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3Months, 6Months, 9Months, 12Months after surgery
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Histology
Time Frame: 1 week after surgery
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Histological analysis
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1 week after surgery
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MGMT (O6-methylguanine-DNA-methyltransferase) analysis
Time Frame: 1 week after surgery
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MGMT promoter analysis (Routine molecular diagnostics)
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1 week after surgery
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IDH-1 (isocitrate dehydrogenase) analysis
Time Frame: 1 week after surgery
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IDH-1 mutation analysis (Routine molecular diagnostics)
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1 week after surgery
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Progression-free survival (PFS)
Time Frame: Day of surgery - 6 months - 12 months
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6M&12M-PFS
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Day of surgery - 6 months - 12 months
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Overall survival (OS)
Time Frame: Day of surgery - Death of patient (Max. 10 years follow-up)
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OS of patients
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Day of surgery - Death of patient (Max. 10 years follow-up)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preoperative tumor localization and resectability concerning eloquent regions
Time Frame: Blinded analysis of preoperative imaging (not older than 3 days prior to surgery)
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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)
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Blinded analysis of preoperative imaging (not older than 3 days prior to surgery)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Constantin Roder, Dr., University Hospital Tuebingen, Department of Neurosurgery
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nch1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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