Novartis Pharma GmbH
Clinical Research Neuroscience

Author Of 2 Presentations

Imaging Poster Presentation

P0603 - MAGNON – Implementation and Contribution of Lublin Criteria and quantitative MRI-Analysis for daily clinical routine of MS Patients (ID 318)

Speakers
Presentation Number
P0603
Presentation Topic
Imaging

Abstract

Background

The revised Lublin criteria (Lublin et al. 2014) provide a detailed definition of individual patient status in secondary progressive multiple sclerosis (SPMS), where patients are assessed annually based on progression and activity (MRI and/or relapse). So far, the revised criteria were applied to SPMS patients only in a small number of studies (Perez et al. EP1344 ECTRIMS 2017). The same is true for quantitative and standardized MRI analyses, which are often implemented in clinical trials, but are not part of standard routine care in patient management, although projects like QUANTUM clearly showed a benefit of quantitative and standardized MRI analysis in routine care (Schippling et al. P508 ECTRIMS 2018).

Objectives

MAGNON aims to evaluate if access to standardized quantification of MRI data and assessment of MS patients based on the Lublin criteria provides additional benefit for neurologists working in day-to-day MS patient management.

Methods

Approximately 3.600 MRI studies of patients with transitioning relapsing remitting MS (RRMS) or SPMS will be provided by 100 centers in Germany. Physicians are asked to categorize their patients according to the revised Lublin criteria. Standardized 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 a volumetric quantification of brain and thalamic volumes as well as T2 lesion volume and number. Percentage brain volume change is computed (using an optimized SIENA pipeline) when follow-up scans are available. The results are visualised and provided to the participating physicians as a report. The value of standardized MRI analysis and the impact on patient assessment, including potential changes in Lublin classification, will be evaluated.

Results

MAGNON will start in the first half of 2020 and design of the project as well as the first baseline data will be presented.

Conclusions

In the near future, an increasing implementation of Lublin criteria and quantitative MRI analysis in routine clinical practice is expected. Quantification of lesion volume as well as brain and thalamic atrophy on routine MRI may facilitate the individual assessment of disease activity and progression according to the Lublin criteria and provide additional information for individual patient management.

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Imaging Poster Presentation

P0629 - QUANTUM – Quantitative and standardized imaging in daily clinical routine of multiple sclerosis patients (ID 1093)

Speakers
Presentation Number
P0629
Presentation Topic
Imaging

Abstract

Background

Magnetic resonance imaging (MRI) analyses play a key role both in treatment monitoring of patients with multiple sclerosis (MS). In MS clinical trials MRI analyses are carried out based on highly standardized protocols, comparable standards are yet to be implemented in routine clinical practice.

Objectives

To evaluate whether standardization of MRI acquisition, volumetric quantification and computerized lesion evaluation of MRI data provides an additional benefit to neurologists working in day-to-day MS patient management.

Methods

From July 2016 until December 2019 297 neurological centers across Germany participated in the QUANTUM project. In total 9,000 MRI data sets from 6.718 MS patients were acquired from 183 radiological centers which all underwent a qualification procedure. Standardized MRI data (3D T1 gradient-echo sequence and 2D/3D FLAIR) were analyzed by a centralized automatic processing pipeline (Biometrica MS®, jung diagnostics GmbH). The analysis comprises volumetric quantification of brain volume, as well as T2 lesion load and number. Percentage brain volume change (using an optimized SIENA pipeline) and T2 lesion activity were computed if follow-up scans were available. The results were visualized and provided to the participating physicians as a report. The benefit and feasibility were evaluated using questionnaires.

Results

Analysis of 8087 questionnaires revealed a good acceptance and usability of the QUANTUM reports. 70% of neurologists reported a strong/very strong correlation between the quantitative MRI parameters and the clinical evaluation of MS patients. More than 74% of neurologists were able to use the report to better classify the patient's disease activity. They rated the additional benefit of the quantitative MRI parameters as high/very high in terms of achieving all four NEDA criteria. 24.4% of the neurologists weighted MRI as more important for therapy decision making than at the beginning of the project. The full data set will be available for presentation.

Conclusions

With QUANTUM standardization of MRI acquisition and MRI evaluation was transferred into daily clinical practice. Volumetric quantification and computerized lesion evaluation can be provided reliably if standardized MRI protocols are used. Quantification of lesion load and volume and visualization of MRI abnormalities might be beneficial for the use of MRI data by neurologists in general and support the individual patient management.

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Presenter Of 1 Presentation

Imaging Poster Presentation

P0629 - QUANTUM – Quantitative and standardized imaging in daily clinical routine of multiple sclerosis patients (ID 1093)

Speakers
Presentation Number
P0629
Presentation Topic
Imaging

Abstract

Background

Magnetic resonance imaging (MRI) analyses play a key role both in treatment monitoring of patients with multiple sclerosis (MS). In MS clinical trials MRI analyses are carried out based on highly standardized protocols, comparable standards are yet to be implemented in routine clinical practice.

Objectives

To evaluate whether standardization of MRI acquisition, volumetric quantification and computerized lesion evaluation of MRI data provides an additional benefit to neurologists working in day-to-day MS patient management.

Methods

From July 2016 until December 2019 297 neurological centers across Germany participated in the QUANTUM project. In total 9,000 MRI data sets from 6.718 MS patients were acquired from 183 radiological centers which all underwent a qualification procedure. Standardized MRI data (3D T1 gradient-echo sequence and 2D/3D FLAIR) were analyzed by a centralized automatic processing pipeline (Biometrica MS®, jung diagnostics GmbH). The analysis comprises volumetric quantification of brain volume, as well as T2 lesion load and number. Percentage brain volume change (using an optimized SIENA pipeline) and T2 lesion activity were computed if follow-up scans were available. The results were visualized and provided to the participating physicians as a report. The benefit and feasibility were evaluated using questionnaires.

Results

Analysis of 8087 questionnaires revealed a good acceptance and usability of the QUANTUM reports. 70% of neurologists reported a strong/very strong correlation between the quantitative MRI parameters and the clinical evaluation of MS patients. More than 74% of neurologists were able to use the report to better classify the patient's disease activity. They rated the additional benefit of the quantitative MRI parameters as high/very high in terms of achieving all four NEDA criteria. 24.4% of the neurologists weighted MRI as more important for therapy decision making than at the beginning of the project. The full data set will be available for presentation.

Conclusions

With QUANTUM standardization of MRI acquisition and MRI evaluation was transferred into daily clinical practice. Volumetric quantification and computerized lesion evaluation can be provided reliably if standardized MRI protocols are used. Quantification of lesion load and volume and visualization of MRI abnormalities might be beneficial for the use of MRI data by neurologists in general and support the individual patient management.

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