TY - JOUR
T1 - Feasibility of brain atrophy measurement in clinical routine without prior standardization of the MRI protocol
T2 - RESULTS from ms-mrius, a longitudinal observational, multicenter real-world Outcome study in patients with relapsing-remitting MS
AU - Zivadinov, R.
AU - Bergsland, N.
AU - Korn, J. R.
AU - Dwyer, M. G.
AU - Khan, N.
AU - Medin, J.
AU - Price, J. C.
AU - Weinstock-Guttman, B.
AU - Silva, D.
AU - Ramasamy, D. P.
AU - Carl, E.
AU - Hunter, S.
AU - Scott, T.
AU - Pandey, K.
AU - Fox, E.
AU - Katz, A.
AU - Silversteen, J.
AU - Kaplan, J.
AU - Maa, E.
AU - Simnad, V.
AU - Shin, R.
AU - Newman, S.
AU - Kinkel, P.
AU - Green, B.
AU - Calkwood, J.
AU - Edwards, K.
AU - Jacobs, D.
AU - Huang, D.
AU - Bass, A.
AU - Hibbs, S.
AU - Kister, I.
AU - Eubank, G.
AU - Pardo, G.
AU - Chitnis, C.
AU - Hendin, B.
AU - Cohan, S.
AU - Freedman, M.
AU - Gudesblatt, M.
AU - Lathi, E.
AU - Alvarez, E.
AU - Goodman, A.
AU - Trudell, R.
AU - Naismith, R.
N1 - Funding Information:
This work was supported by Novartis Pharmaceuticals AG, Switzerland.
Funding Information:
Disclosures: Robert Zivadinov—RELATED: Grant: QuintilesIMS*; UNRELATED: Consultancy: Novartis, Sanofi Genzyme, Celgene; Grants/Grants Pending: Novartis, Sanofi Genzyme, QuintilesIMS*; Payment for Lectures Including Service on Speakers Bureaus: Novartis, Sanofi Genzyme. Jonathan R. Korn—RELATED: Consulting Fee or Honorarium: QuintilesIMS, Comments: QuintilesIMS received funding from No-vartis to perform this study.* Michael G. Dwyer—RELATED: Grant: Novartis*; UNRELATED: Consultancy: Claret Medical, EMD Serono. Nasreen Khan—RELATED: Consulting Fee or Honorarium: QuintilesIMS, Comments: The work performed was paid by QuintilesIMS. The QuintilesIMS study was supported by Novartis; UNRELATED: Employment: Real-World Economics Consultancy, Comments: I am the owner of the consultancy firm Real-World Economics Consultancy, which provides consulting services for pharmaceutical and other consulting companies. In the past, I have worked with QuintilesIMS and Novartis. Jennie Medin—RELATED: Support for Travel to Meetings for the Study or Other Purposes: Novartis, Comments: I am a paid employee of Novartis; Fees for Participation in Review Activities such as Data Monitoring Boards, Statistical Analysis, Endpoint Committees, and the Like: No-vartis, Comments: I am a paid employee of Novartis; Other: Novartis, Comments: I am a paid employee of Novartis Pharma AG; UNRELATED: Employment: Novartis, Comments: I am a paid employee of Novartis; Payment for Manuscript Preparation: Novartis, Comments: I am a paid employee of Novartis; Stock/Stock Options: No-vartis, Comments: I am a paid employee of Novartis; Travel/Accommodations/ Meeting Expenses Unrelated to Activities Listed: Novartis, Comments: I am a paid employee of Novartis; Other: Novartis, Comments: I am a paid employee of No-vartis. Jennifer C. Price—RELATED: Other: QuintilesIMS, Comments: I am a paid employee of QuintilesIMS, which was paid by Novartis to perform this study; UNRELATED: Employment: QuintilesIMS, Comments: I am a paid employee of Quin-tilesIMS. Bianca Weinstock-Guttman—RELATED: Grant: Novartis*; UNRELATED: Consultancy: Biogen, TEVA, Novartis, Genzyme, Genetech, EMD Serono; Payment for Lectures Including Service on Speakers Bureaus: Biogen, TEVA, Novartis, Genen-tech. Diego Silva—RELATED: Other: Novartis, Comments: I am a Novartis employee; UNRELATED: Employment: Novartis; Stock/Stock Options: Novartis, Comments: I am a Novartis employee. *Money paid to the institution.
PY - 2018/2/1
Y1 - 2018/2/1
N2 - BACKGROUND AND PURPOSE: Feasibility of brain atrophy measurement in patients with MS in clinical routine, without prior standardization of the MRI protocol, is unknown. Our aim was to investigate the feasibility of brain atrophy measurement in patients with MS in clinical routine. MATERIALS AND METHODS: Multiple Sclerosis and Clinical Outcome and MR Imaging in the United States (MS-MRIUS) is a multicenter (33 sites), retrospective study that included patients with relapsing-remitting MS who began treatment with fingolimod. Brain MR imaging examinations previously acquired at the baseline and follow-up periods on 1.5T or 3T scanners with no prior standardization were used, to resemble a real-world situation. Brain atrophy outcomes included the percentage brain volume change measured by structural image evaluation with normalization of atrophy on 2D-T1-weighted imaging and 3D-T1WI and the percentage lateral ventricle volume change, measured by VIENA on 2D-T1WI and 3D-T1WI and NeuroSTREAM on T2-fluid-attenuated inversion recovery examinations. RESULTS: A total of 590 patients, followed for 16 months, were included. There were 585 (99.2%) T2-FLAIR 425 (72%) 2D-T1WI, and 166 (28.2%) 3D-T1WI longitudinal pairs of examinations available. Excluding MR imaging examinations with scanner changes, the analyses were available on 388 (65.8%) patients on T2-FLAIRfor the percentage lateral ventricle volume change, 259 and 257 (43.9% and 43.6%, respectively) on 2D-T1WI for the percentage brain volume change and the percentage lateral ventricle volume change, and 110 (18.6%) on 3D-T1WI for the percentage brain volume change and percentage lateral ventricle volume change. The median annualized percentage brain volume change was -0.31% on 2D-T1WI and -0.38% on 3D-T1WI. The median annualized percentage lateral ventricle volume change was 0.95% on 2D-T1WI, 1.47% on 3D-T1WI, and 0.90% on T2-FLAIR CONCLUSIONS: Brain atrophy was more readily assessed by estimating the percentage lateral ventricle volume change on T2-FLAIR compared with the percentage brain volume change or percentage lateral ventricle volume change using 2D- or 3D-T1WI in this observational retrospective study. Although measurement of the percentage brain volume change on 3D-T1WI remains the criterion standard and should be encouraged in future prospective studies, T2-FLAIR-derived percentage lateral ventricle volume change may be a more feasible surrogate when historical or other practical constraints limit the availability of percentage brain volume change on 3D-T1WI.
AB - BACKGROUND AND PURPOSE: Feasibility of brain atrophy measurement in patients with MS in clinical routine, without prior standardization of the MRI protocol, is unknown. Our aim was to investigate the feasibility of brain atrophy measurement in patients with MS in clinical routine. MATERIALS AND METHODS: Multiple Sclerosis and Clinical Outcome and MR Imaging in the United States (MS-MRIUS) is a multicenter (33 sites), retrospective study that included patients with relapsing-remitting MS who began treatment with fingolimod. Brain MR imaging examinations previously acquired at the baseline and follow-up periods on 1.5T or 3T scanners with no prior standardization were used, to resemble a real-world situation. Brain atrophy outcomes included the percentage brain volume change measured by structural image evaluation with normalization of atrophy on 2D-T1-weighted imaging and 3D-T1WI and the percentage lateral ventricle volume change, measured by VIENA on 2D-T1WI and 3D-T1WI and NeuroSTREAM on T2-fluid-attenuated inversion recovery examinations. RESULTS: A total of 590 patients, followed for 16 months, were included. There were 585 (99.2%) T2-FLAIR 425 (72%) 2D-T1WI, and 166 (28.2%) 3D-T1WI longitudinal pairs of examinations available. Excluding MR imaging examinations with scanner changes, the analyses were available on 388 (65.8%) patients on T2-FLAIRfor the percentage lateral ventricle volume change, 259 and 257 (43.9% and 43.6%, respectively) on 2D-T1WI for the percentage brain volume change and the percentage lateral ventricle volume change, and 110 (18.6%) on 3D-T1WI for the percentage brain volume change and percentage lateral ventricle volume change. The median annualized percentage brain volume change was -0.31% on 2D-T1WI and -0.38% on 3D-T1WI. The median annualized percentage lateral ventricle volume change was 0.95% on 2D-T1WI, 1.47% on 3D-T1WI, and 0.90% on T2-FLAIR CONCLUSIONS: Brain atrophy was more readily assessed by estimating the percentage lateral ventricle volume change on T2-FLAIR compared with the percentage brain volume change or percentage lateral ventricle volume change using 2D- or 3D-T1WI in this observational retrospective study. Although measurement of the percentage brain volume change on 3D-T1WI remains the criterion standard and should be encouraged in future prospective studies, T2-FLAIR-derived percentage lateral ventricle volume change may be a more feasible surrogate when historical or other practical constraints limit the availability of percentage brain volume change on 3D-T1WI.
UR - http://www.scopus.com/inward/record.url?scp=85042160705&partnerID=8YFLogxK
U2 - 10.3174/ajnr.A5442
DO - 10.3174/ajnr.A5442
M3 - Article
C2 - 29170269
AN - SCOPUS:85042160705
SN - 0195-6108
VL - 39
SP - 289
EP - 295
JO - American Journal of Neuroradiology
JF - American Journal of Neuroradiology
IS - 2
ER -