INSPIRATION-MRI: Standardized Acquisition and Centralized Quantitative Reading of MRI Scans of RRMS Patients in German Daily Clinical Practice (S45.004)

Objective: MRI has become an integral part of MS-patient management. However, quantitative analysis of lesion-load is not trivial and has mainly been realized in clinical trials. We investigate whether additional quantitative information and visualization of lesion-load is regarded useful in the daily management of RRMS-patients. Background: INSPIRATION-MRI is a non-interventional study, conducted in Germany, to validate the feasibility and potential benefit of standardized MRI-acquisition and central-quantitative MRI-reading in clinical practice for RRMS-patients. Methods: This NIS included 253 patients, in 18 centers. Sites underwent expert training and sequence implementation employing standardized MRI-sequences. In addition to routine local diagnostic reading, a centralized quantitative MRI-data analysis is performed (volume of T2-lesions, T1-hypointense and contrast-enhancing lesions, percentage of brain volume change via boundary shift integral). The results are visualized and provided to the physicians. Results: 251 of 253 (99.2[percnt]) baseline data sets passed MRI-data quality analysis (consistency, artifacts, signal-to-noise-ratio, contrast-to-noise-ratio). 35.1[percnt] of the patients were treated with fingolimod upon study inclusion (21.5[percnt] interferons, 17.5[percnt] dimethylfumarate, 6.8 [percnt] natalizumab, 6.8[percnt] copaxone, 12.3[percnt] no/other). The mean number (±SD)/ml volume (±SD) of T2/FLAIR lesions at baseline was 30.1 (±2.8)/11033.1 (±1578.9), of black holes 4.0 (±0.9)/490.3 (±135.5) and of CM enhancing lesions 0.4 (±0.2)/31.1 (±20.3). The lesion count of T2/FLAIR lesions differed between neurologists (lesion count ≥9: 48.2[percnt]), radiologists (64.9[percnt]) and central reading (80.9[percnt]). Conclusions: More sophisticated, additional quantitative MRI-analysis is provided in a real world situation. A common standardized analysis of MRI data for several centers revealed differences between the individual estimation of lesion numbers by the centers and the quantitative approach of the central reading centers. A common analysis might improve the comparability of individual MRI scans. The quantitation of lesion load and volumes and visualization of MRI-abnormalities may facilitate MRI-data use by the responsible neurologist to support patient management. Disclosure: Prof. Gass received personal compensation from activities with Biogen Idec and Novartis. Dr. Gregori has received personal compensation for activities with Mediri as an employee. Dr. Hoffmann has received personal compensation for activities with Mediri GmbH as an employee. Dr. Fuchs has received personal compensation for activities with Novartis. Dr. Cornelissen has received personal compensation for activities with Novartis as an employee.