Contributions
Abstract: EP1530
Type: ePoster
Abstract Category: Pathology and pathogenesis of MS - 21 Imaging
Background: Magnetic resonance imaging (MRI) analyses play a key role both in the diagnosis and in treatment monitoring of patients with multiple sclerosis (MS). While reliable, quantitative analyses of highly standardised MRIs are carried out in clinical trials, comparable standards are yet to be implemented in clinical routine.
Aim: The data collection QUANTUM aims to evaluate if access to standardised quantification of MRI data and visualisation in reports, in addition to radiological findings provides additional benefit for neurologists working in day-to-day MS patient management.
Methods: Approximately 3,000 MRI analyses will be performed in 200 participating centres in Germany . The standardised MRI data (3D T1 gradient-echo sequence and 2D/3D FLAIR) are analysed by means of a centralised automatic processing pipeline (Biometrica MS®, jung diagnostics GmbH). The analysis comprises of a volumetric quantification of brain volume, as well as T2 lesion load and number. Percentage brain volume change is computed (using optimized SIENA pipeline) after the availability of follow-up scans. Scanner specific effects are accounted for using normative data sets for healthy controls generated for each individual MRI platform. The results are visualised and provided to the participating physicians as a report. The value and feasibility are evaluated using a questionnaire.
Results: QUANTUM started in June 2016. 60 radiological centres across Germany built-up scanner-specific data sets of healthy controls. By mid-2017, approximately 100 neurological centres would participate in the project and up to 1,000 MRIs would be analysed. The design used in data collection,
the MRI protocol, and details of the centralised processing pipeline as well as baseline data from the first 100 centres will be presented.
Conclusion: In the course of the QUANTUM study, standardised MRI and MRI evaluations that were previously restricted to the clinical trial setting or expert sites were broadly made available. The optimisation of MRI protocols, the correction for scanner effects by means of scanner-specific control data and visualised reports could help to overcome limitations of comparable but less systematic approaches in routine clinical MS care. In addition and when fully initiated, data collected in the context of QUANTUM carries unique potential to improve the quality of imaging data collected in so-called “real-world registries” in the future.
Disclosure: Project is funded by Novartis Pharma GmbH, Nuernberg,Germany.
Sven Schippling reports receiving research grants from Novartis and Sanofi Genzyme; and consulting and speaking fees from Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva. Ann-Christin Ostwaldt is employee of Jung Diagnostics GmbH, Hamburg, Germany
Lothar Spies is employee of Jung Diagnostics GmbH, Hamburg, Germany
Roland Opfer is employee of Jung Diagnostics GmbH, Hamburg, Germany
Katrin Schuh is employee of Novartis Pharma GmbH, Nuremberg, Germany
Abstract: EP1530
Type: ePoster
Abstract Category: Pathology and pathogenesis of MS - 21 Imaging
Background: Magnetic resonance imaging (MRI) analyses play a key role both in the diagnosis and in treatment monitoring of patients with multiple sclerosis (MS). While reliable, quantitative analyses of highly standardised MRIs are carried out in clinical trials, comparable standards are yet to be implemented in clinical routine.
Aim: The data collection QUANTUM aims to evaluate if access to standardised quantification of MRI data and visualisation in reports, in addition to radiological findings provides additional benefit for neurologists working in day-to-day MS patient management.
Methods: Approximately 3,000 MRI analyses will be performed in 200 participating centres in Germany . The standardised MRI data (3D T1 gradient-echo sequence and 2D/3D FLAIR) are analysed by means of a centralised automatic processing pipeline (Biometrica MS®, jung diagnostics GmbH). The analysis comprises of a volumetric quantification of brain volume, as well as T2 lesion load and number. Percentage brain volume change is computed (using optimized SIENA pipeline) after the availability of follow-up scans. Scanner specific effects are accounted for using normative data sets for healthy controls generated for each individual MRI platform. The results are visualised and provided to the participating physicians as a report. The value and feasibility are evaluated using a questionnaire.
Results: QUANTUM started in June 2016. 60 radiological centres across Germany built-up scanner-specific data sets of healthy controls. By mid-2017, approximately 100 neurological centres would participate in the project and up to 1,000 MRIs would be analysed. The design used in data collection,
the MRI protocol, and details of the centralised processing pipeline as well as baseline data from the first 100 centres will be presented.
Conclusion: In the course of the QUANTUM study, standardised MRI and MRI evaluations that were previously restricted to the clinical trial setting or expert sites were broadly made available. The optimisation of MRI protocols, the correction for scanner effects by means of scanner-specific control data and visualised reports could help to overcome limitations of comparable but less systematic approaches in routine clinical MS care. In addition and when fully initiated, data collected in the context of QUANTUM carries unique potential to improve the quality of imaging data collected in so-called “real-world registries” in the future.
Disclosure: Project is funded by Novartis Pharma GmbH, Nuernberg,Germany.
Sven Schippling reports receiving research grants from Novartis and Sanofi Genzyme; and consulting and speaking fees from Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva. Ann-Christin Ostwaldt is employee of Jung Diagnostics GmbH, Hamburg, Germany
Lothar Spies is employee of Jung Diagnostics GmbH, Hamburg, Germany
Roland Opfer is employee of Jung Diagnostics GmbH, Hamburg, Germany
Katrin Schuh is employee of Novartis Pharma GmbH, Nuremberg, Germany